National Organic Standards Board | Spring 2014 Meeting | Proposals & Discussion Documents

TOC

National Organic Standards Board Meeting

St. Anthony Hotel, Anacacho Ballroom, San Antonio, TX April 29 – May 2, 2014 

Title Page

Agenda 

Agenda i

Crops Subcommittee | Zea Sonnabend, Chairperson 

*Proposal: Streptomycin - petitioned 1

*Proposal: Magnesium Oxide - petitioned 19

+Proposal: Vinasse - petitioned 25

+Proposal: Laminarin - petitioned 29

Update: Inerts (NO DOCUMENT) NONE

*Sunset 2015 Summary: Sulfurous Acid, Sodium Carbonate Peroxyhydrate, Aqueous 

 Potassium Silicate 

33

Livestock Subcommittee |Tracy Favre, Chairperson

Proposal: Methionine in Organic Poultry Feed (MET) - petitioned 39

Proposal: Acidified Sodium Chlorite (ASC) - petitioned 45

Verbal update: Vaccines from Excluded Methods (GMO Vaccines) (NO DOCUMENT) NONE

*Proposal: Aquaculture - Chlorine (for aquatic animals) - petitioned 49

*Proposal: Aquaculture - Tocopherols (for aquatic animals) - petitioned 55

*Proposal: Aquaculture - Minerals (for aquatic animals) - petitioned 63

Proposal: Aquaculture - Vitamins (for aquatic animals) - petitioned 69

+Proposal: Aquaculture - Biologics: Vaccines (for aquatic animals) - petitioned 75

+Proposal: Aquaculture - Micronutrients (for aquatic plants) - petitioned 83

+Proposal: Aquaculture - CO2 (for aquatic plants) - petitioned 89

+Proposal: Aquaculture - Chlorine (for aquatic plants) - petitioned 97

+Proposal: Aquaculture - Lignin Sulfonate (for aquatic plants) - petitioned 105

+Proposal: Aquaculture - Vitamins B1, B12, H (for aquatic plants) - petitioned 113
TOC

Compliance, Accreditation, and Certification Subcommittee | Carmela Beck, Chairperson

*Proposal: Guidance on Retail Certification 121

Proposal: Clarifying Accredited Certifiers Agents’ Application of 205.206(e) 131

Update: Sound and Sensible (NO DOCUMENT) NONE

Handling Subcommittee | Harold Austin, Chairperson

*Proposal: Ammonium Hydroxide (boiler water additive) - petitioned 135

Proposal: Glycerin – petitioned for removal 141

Discussion Document: Polyalkylene Glycol Monobutyl Ether (PGME) - petitioned 149

Update: Ancillary Substances (NO DOCUMENT) NONE

*Sunset 2015 Summary: Gellan gum, Tragacanth, Marsala, Sherry

 

153

Materials Subcommittee | C. Reuben (Calvin) Walker, Chairperson

Proposal: Update of Petition and TR process 159

Proposal: Confidential Business Information (CBI) 167

Proposal: Fall 2013 Research Priorities 171

+Report/Update: Seed purity from GMOs 177

**IMPORTANT NOTE REGARDING PUBLIC COMMENTS**

Many of the proposals that would have been discussed at the cancelled October 2013 NOSB 

meeting will be discussed at the April 2014 meeting instead. If you submitted comments at 

that time, and the NOSB has not revised the proposal, you DO NOT need to resubmit your 

comments. See key below for proposal status. 

* Fall 2013 document revised

+ New for spring 2014

 Lack of notation indicates no revisions to fall 2013 document
USDA-AMS | National Organic Program

 National Organic Standards Board | Spring 2014 Draft Meeting Agenda Rev 03/08/2014 

 i 

National Organic Standards Board Meeting

St. Anthony Hotel, 300 East Travis Street, San Antonio, TX 78205 Anacacho Ballroom

April 29 – May 2, 2014 

Tentative Agenda 

Schedule at a Glance

Tuesday 

April 29

Wednesday

April 30

Thursday

May 1

Friday 

May 2

MORNING

- Call to Order 

 - NOP Update 

 - Policy Development Subcommittee 

 - Presentation: Organic 

 Agriculture at USDA

 - Overview of USDA NRCS

 - Discussion: Overarching Ideas 

 and Undercurrents in Organics 

- Public 

 Comment 

 

- Livestock Subcommittee - Deferred Items/Final 

 Votes 

- NOSB Officer Elections 

 - Subcommittee 

 Work Plans 

 - Other Business/ 

 Closing Remarks 

- Adjourn

AFTERNOON

- Materials Update/ 

 Process Overview 

 - Public Comment 

 

- Crops 

 Subcommittee 

 

- Compliance, Accreditation 

 & Certification 

 Subcommittee 

- Handling Subcommittee 

- Materials Subcommittee

Meeting Format

• The USDA National Organic Program (NOP) National List Manager presents an overview of petitioned 

substances and Technical Reports in consistent format. 

• The Board hears public comments, which are grouped by topic to facilitate review. 

• NOSB members present and discuss Subcommittee proposals and discussion documents; NOSB votes on 

proposals. Final votes may be deferred to Friday May 2, 2014 if more deliberation is needed. 

• NOTE: Agenda items may be withdrawn or votes may be postponed at the discretion of the Board. 

• There will be two 15-minute breaks (mid-morning & mid-afternoon) and a 1 hr & 15-minute lunch break mid-day

Public Comments 

**IMPORTANT NOTE REGARDING WRITTEN PUBLIC COMMENTS**

• Many of the proposals that would have been discussed at the cancelled October 2013 NOSB meeting will be 

discussed at the April 2014 meeting instead. If you submitted comments at that time, and the NOSB has not 

revised the proposal, you DO NOT need to resubmit your comments. If a document was revised, it is noted 

below by a “*”. If a proposal is new for spring 2014 it is marked with a “+”. This is also noted on the 

Subcommittee proposals webpages, and at the top of each proposal. 

• If you signed up for in-person oral comments for fall 2013, you WILL have to do so again for spring 2014. 

• All persons wishing to comment at NOSB meetings during the public comment period must sign up in advance. 

Instructions are available at www.ams.usda.gov/NOSBMeetings. Speaking slots for walk-in commenters are not 

guaranteed. Walk-in commenters can sign up in person at the meeting if the schedule allows.

• Each commenter must state his/her name and affiliation for the record at the beginning of their comment.
USDA-AMS | National Organic Program

 National Organic Standards Board | Spring 2014 Draft Meeting Agenda Rev 03/08/2014 

 ii 

• Each person may sign up for only one speaking slot, followed by time for questions from the Board. The amount 

of time provided for each commenter will be determined by the number of commenters and the time available. 

Tuesday, April 29, 2014

8:30 AM Call to Order, Ground Rules, Agenda Overview

Miles McEvoy, AMS Deputy Administrator, Designated Federal Officer

Announcements, Introductions, NOSB Mission

Mac Stone, Chairperson and John Foster, Vice Chairperson

Secretary’s Report, Acceptance of April 2013 Meeting Transcripts and Voting Results as 

Official Record

Dr. C. Reuben (Calvin) Walker, Secretary

National Organic Program update, OFPA, FACA, NOSB Charter, NOSB Evaluation and 

Operating Guidelines

Miles McEvoy, Deputy Administrator

Policy Development Subcommittee

Dr. Jean Richardson, Chairperson

 Topics:

 Update on status of PDS and fall 2013 documents

Organic Agriculture at USDA 

Mark Lipson, USDA Organic Policy Coordinator/Chair of USDA’s Organic Working Group

Overview of USDA Natural Resource Conservation Service (NRCS)

NRCS Staff

Discussion: Overarching Ideas and Undercurrents in Organics/Outcomes from NOSB 

Training and NOSB Evaluation 

NOSB

National Organic Program - Materials Update/Process Overview

Dr. Melissa Bailey, Director, Standards Division; Dr. Lisa M. Brines, NOP National List Manager

Summary of New and Outstanding Petitions

Petition Process

Rulemaking Process

Sunset Review Process

2:45 PM Public Comment 

5:30 PM RECESS
USDA-AMS | National Organic Program

 National Organic Standards Board | Spring 2014 Draft Meeting Agenda Rev 03/08/2014 

 iii 

* Fall 2013 document revised

+ New for spring 2014

 Lack of notation indicates no revisions to fall 2013 document Wednesday, April 30

8:30 AM Public Comment 

2:45 PM Crops Subcommittee 

Zea Sonnabend, Chairperson 

Present Subcommittee proposals and summarize written comments

 Topics:

 *Proposal: Streptomycin - petitioned

 *Proposal: Magnesium Oxide - petitioned 

 + Proposal: Vinasse - petitioned 

 + Proposal: Laminarin - petitioned

 Verbal update: Inerts (no document)

 *Sunset 2015 Review List: 

 Sulfurous Acid

 Sodium Carbonate Peroxyhydrate

 Aqueous Potassium Silicate

5:30 PM RECESS

Thursday, May 1

8:30 AM Livestock Subcommittee 

Tracy Favre, Chairperson 

Present Subcommittee proposals and summarize written comments 

Topics: 

 Proposal: Methionine in Organic Poultry Feed (MET) - petitioned

 Proposal: Acidified Sodium Chlorite (ASC) - petitioned 

 Verbal update: Vaccines from Excluded Methods (GMO Vaccines) (no document)

*Proposal: Aquaculture - Chlorine (for aquatic animals) - petitioned

*Proposal: Aquaculture - Tocopherols (for aquatic animals) - petitioned

*Proposal: Aquaculture - Minerals (for aquatic animals) - petitioned 

 Proposal: Aquaculture - Vitamins (for aquatic animals) - petitioned

+Proposal: Aquaculture - Biologics: Vaccines (for aquatic animals) – petitioned 

+Proposal: Aquaculture - Micronutrients (for aquatic plants) - petitioned

+Proposal: Aquaculture - CO2 (for aquatic plants) - petitioned

+Proposal: Aquaculture - Chlorine (for aquatic plants) - petitioned

+Proposal: Aquaculture - Lignin Sulfonate (for aquatic plants) - petitioned

+Proposal: Aquaculture - Vitamins B1, B12, H (for aquatic plants) - petitioned

 
USDA-AMS | National Organic Program

 National Organic Standards Board | Spring 2014 Draft Meeting Agenda Rev 03/08/2014 

 iv 

1:30 PM Compliance, Accreditation and Certification Subcommittee 

Carmela Beck, Chairperson

Present Subcommittee proposals and summarize written comments

 Topics: 

 *Proposal: Guidance on Retail Certification

 Proposal: Clarifying Accredited Certifying Agents’ Application of §205.206(e)

 Verbal Summary/Update: Sound and Sensible (no document)

2:30 PM Handling Subcommittee

Harold Austin, Chairperson

Present Subcommittee proposals and summarize written comments

Topics: 

*Proposal: Ammonium Hydroxide (boiler water additive) - petitioned 

 Proposal: Glycerin - petitioned for removal

 Discussion Document: Polyalkylene Glycol Monobutyl Ether (PGME) - petitioned 

 Update: Ancillary Substances (no document)

*Sunset 2015 Review List: 

 Gellan Gum 

 Tragacanth Gum

 Marsala 

 Sherry 

4:15 PM Materials Subcommittee 

Dr. C. Reuben (Calvin) Walker, Chairperson

Present Subcommittee proposals and summarize written comments 

Topics: 

 Proposal: Update of Petition & Technical Review Process 

 Proposal: Confidential Business Information in Petitions (CBI) 

 Proposal: Fall 2013 Research Priorities

+ Written report: Seed Purity from GMOs

5:30 PM RECESS

Friday, May 2

8:30 AM Deferred Proposals/Final Votes 

NOSB Officer Elections

Subcommittee Workplans

Other Business and Closing Remarks

12:30 PM ADJOURN
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Streptomycin

August 6, 2013

*Reviewed and revised February 18, 2014

Discussion Summary: 

The NOSB has been petitioned to remove the existing expiration date of October 21, 2014 for 

Streptomycin and replace it with a new one of Oct 21, 2017, for both apples and pears. The 

petitioner states that this would allow adequate time for the transition from strep over to nonantibiotic, biological alternatives for fire blight control.

There are two different positions on this subject: those that support the petition request for an 

extension and those that oppose an extension.

Both sides agree that it is time for a phase out for the allowed use of strep. The supporters 

believe that three additional years until October 2017 is reasonable, and opponents believe that 

yet another extension offers no assurance of phase out.

Proponents of an extension feel that:

~Because of the investment involved to establish an orchard (as well as the businesses 

established to handle this produce) in both time, money, and the need for completion 

of existing research of materials, that a slowdown (or extension) of the expiration date 

is needed, especially for pear growers.

~This slow down would benefit growers, processors, producers, handlers, and 

consumers alike.

~Alternative materials are still not readily showing consistent control and one material’s 

registration (Previsto copper) has been delayed by EPA. Thus, the farmers still need 

some additional time in order to prepare for the transition to a non-antibiotic fire blight 

control period in time.

•Opponents feel that:

~Fire blight resistance to streptomycin is widespread in the U.S.

~Raise the question of essentiality, based on the significant percentage of growers 

selling to markets that do not allow antibiotic treatments.

~Organic integrity and sales are threatened because of consumer expectation that 

antibiotics are not used in organic production.

•Both sides agree that the “core” issue here is whether or not there is a risk of enhancing 

antibiotic resistance in human pathogens. There is science that supports both sides of this 

argument and the level of concerns that are raised by this particular use pattern. Supporters cite 

issues of use patterns and limits of residues as indicative of no evidence of harm. Opponents 

cite resistant human pathogens in strep treated orchards and horizontal gene transfer identified 

as leading to antibiotic resistance.

•While there has been a direct linkage shown to exist between infection and colonization of 

humans by antibiotic resistant bacteria in animals (Larsen et al 2010), supporters cite no direct 

linkage has been demonstrated between antibiotic resistant bacteria in humans and antibiotic 

sprays applied to plants (Stockwell and Duffy, 2012), such as the current use of strep in apples 

and pears for fire blight control. Lab results vary in their conclusions. Opponents cite evidence 

1/186
that bacteria, including Erwinia amylovora and human pathogens, share a common genetic 

basis for resistance, transmitted by plasmids, to streptomycin in particular. (McGhee et al, 2010; 

Sundin, 2000; Sundin and Bender, 1996; Pezzella et al, 2004; Scherer et al, 2013; Foster et al, 

2004.)

•Proponents state: there is no evidence that applications of antibiotics to orchards during bloom 

contributes to antibiotic resistance in human pathogens. The amount and timing of the use of 

strep in an orchard environment does not contribute to any human health concerns, especially 

in light of streptomycin being ineffective in humans when ingested orally.

•Opponents state: there is evidence that an application of strep leads to an increase in 

resistance to streptomycin in orchard bacteria, that human pathogens and fire blight bacteria 

share the same gene pool of genes resistant to streptomycin (i.e. that the same genes 

responsible for resistance in Erwinia amylovora are also responsible for resistance in human 

pathogens), that human pathogens do not need to be present in the orchard to obtain resistance 

genes acquired by and augmented in orchard bacteria, that strep residues are sometimes 

present in treated fruit, and that strep is still a critically important antimicrobial for use against 

human pathogens.

•The primary point of discussion here is whether to grant an extension or not to the current 

expiration date for streptomycin in October 2014. The points proponents say should be 

considered are: What impact does an extension/or non-extension have on the stakeholders that 

either use this material or have built their businesses around expanded crop availability; How 

will a decision impact the supply chain, How will a decision impact the consumer (all consumers, 

not just a select group(s)), What are the risks/if any for granting an extension or not, and would 

granting a short extension for allowed use knowing what the use patterns are pose any 

significant increases in human health concerns from resistance than currently exist today? 

•The points opponents say should be considered are: What impact does yet another extension, 

which was first called for by the NOSB in 1995, have on the integrity of the organic label? What 

are the public health hazards of using antibiotics for nontherapeutic uses and why are infectious 

disease doctors concerned? What is the threat of low-level environmental exposure to 

antibiotics? What are the alternative strategies that are used to manage or prevent fire blight?

•Remember, according to proponents, this is not a new material, but one that has been on the 

National List of Approved Materials for a number of years as being allowed for use by organic 

growers to use on their organically grown and certified crops. Opponents point to long-standing 

NOSB attempts to phase out the use of antibiotics in organic apple and pear production, with 

votes by previous boards to phase-out, only to have subsequent boards issue extensions.

•One other point of discussion, proponents state that this would be a way to ensure a full 

expiration of strep from the National List, if an extension for use were to happen. They ask, how 

could we ensure all stakeholders that there would be an absolute point when this usage would 

truly expire? Opponents, who would like the 2014 antibiotic expiration date to take effect, 

believe that the debate on antibiotics and votes to phase them out by previous boards have 

resulted in only extended deadlines for too long, and organic should not in any way contribute to 

the worldwide crisis in antibiotic resistance, while ultimately threatening consumer confidence in 

the organic label.

New text: 

Oral and written public comments (Docket AMS-NOP-13-0049) from pear growers noted that 

especially in the 2013 season, Blossom Protect did not work well in the Pacific Northwest and 

California. (The manufacturer of Blossom Protect does not agree with this statement and voiced 

2/186
their disagreement during the written public comment period prior to the canceled fall 2013 

NOSB meeting.) It was an unusually warm spring. The copper material that is very promising 

has been delayed in registration until at least 2014 nationwide and 2015 in California.

Summary of Proposed Action:

The Crops Subcommittee proposes to: 

Remove the existing expiration date of October 21, 2014 for streptomycin and replace it with a 

new expiration date of October 21, 2017. This would be for use in both apples and pears for 

control of fire blight.

The Crops Subcommittee puts forward this resolution:

Resolution: The National Organic Standards Board is committed to the phase out of this 

material. Between now and the expiration date the Board urges growers and certifiers to include 

in organic systems plans an annual increase in the extent and/or number of alternative practices 

and materials that are trialed for controlling fire blight. In addition, the board strongly advocates 

to USDA a high priority for increased support for research into these alternative practices and 

materials.

Introduction

A Petition to the National Organic Standards Board (NOSB) was received for the Removal of 

the Expiration Date (October 21, 2014) for streptomycin and the establishment of October 21, 

2017 as its sunset date, in order to allow for adequate time for the transition to proven effective 

non-antibiotic, i.e. biological alternatives for fire blight control in apples and pears.

Because this subject is complex and there are two different positions to be represented, this 

recommendation is organized to present two separate positions - those for and those against an 

extension. These are designed to supplement the points raised in the checklist. Most of the 

same background presented in the spring 2013 Recommendation for Oxytetracycline is relevant 

to Streptomycin, except for the 2007 and 2008 actions.

The subcommittee acknowledges the concerns of consumers and previous NOSB members 

who feel that it is time to phase this material out from organic agriculture. The two positions 

represented in the discussion section of this document differ on the timing of the phase-out. 

Additional concerns are being put forward in a separate resolution on the subject.

Points of Agreement and Disagreement

This section focusses on how the material is used in the context of both plant and human 

health. Because much of the general information was covered in the proposal for 

Oxytetracycline, this review focusses on the differences and similarities between the two 

materials. Specific portions address Checklist categories as noted.

1. Fire blight control

Proponents of both positions agree that orchard establishment requires a large investment of 

time and money, that apples and pears are grown in a variety of locations that require different 

management plans, and that more research is needed into systems for preventing fire blight 

damage. 

3/186
Proponents of extending the expiration date of streptomycin say:

• Because of the very large investment of time and money that establishing an orchard 

entails, the variety of locations that apples and pears are grown, and the very 

rudimentary state of research on alternatives to this material in that variety of locations, 

we are supporting slowing down the removal of streptomycin from the National List.

• Since the organic pear industry is more at risk to fire blight than apples there is concern 

that pear research and control measures are lagging behind and that an expanded time 

frame will be needed. Streptomycin is still fairly widely used in pears, especially those 

grown in areas with high humidity and warm springs.

• A slightly extended date of 2017 will benefit consumers and growers alike. The few more 

seasons of research will enable new products to be tested in both apples and pears in a 

variety of weather conditions.

• In 2009, about 15% of the total apple area and 40% of the pears (organic and 

conventional) were treated with streptomycin or oxytetracycline for control of Fireblight, 

the disease caused by the bacteria Erwinia amylovora.

1

• Experience of pear growers especially in the 2013 season has shown that Blossom 

Protect has not worked well in the Pacific Northwest or California. It was an unusually 

warm spring. The copper material that is very promising has been delayed in registration 

until at least 2014 nationwide and 2015 in California.

Opponents to extending the expiration date of streptomycin say:

• Like most challenges in organic production systems, with fire blight there is no one 

material and no one practice that will eliminate the problem. Fire blight must be met with 

a truly organic systems approach that is sensitive to the potential adverse health and 

environmental effects of inputs and consumer expectations.2

 

• Fire blight resistance to streptomycin is widespread in the United States. Streptomycinresistant strains of fire blight have been found in California, Oregon, Washington, 

Michigan, New York,3 Missouri,4 and Utah.5 Plasmid-borne genes have been found to 

confer resistance in California, Michigan,6 and New York.7

 

• With regard to the “essentiality” of streptomycin, not all organic apple and pear growers 

depend on antibiotics. In fact, there is a sizeable proportion of growers of both apples 

and pears who do not use antibiotics. 

• As of March 10, 2011, there were 96 businesses certified as EU-compliant organic 

producers of apples and/or pears in the state of Washington alone, representing about 

one third of the state’s organic apple and one fourth of the state’s organic pear 

production. EU-compliant organic apple and pear growers cannot use antibiotics, and 

face a three-year ban from selling in the EU if they do.8 In addition, cultural changes in 

the orchard environment have contributed to epidemics of fire blight.9

 

2. Need for phase out of streptomycin

The sub-committee acknowledges the concerns of consumers and previous NOSB members 

who feel that it is time to phase this material out from organic agriculture. The two positions 

represented in the discussion section of this document differ on the timing of the phase-out.

4/186
Proponents of an extension for streptomycin say:

Because of the need to make sure that this material is phased out, a resolution motion has been 

added to affirm the commitment by the NOSB to all organic stakeholders. The NOSB must 

ensure that the decisions made reflect due consideration of the various needs and concerns of 

the vast array of all our organic stakeholders, especially when dealing with complicated issues, 

such as this one. 

Additionally, in spite of the claims below about the threat of spreading resistance to 

streptomycin, most of the research on this subject has been conducted with antibiotics used in 

livestock and very little in orchard environments. Some very recent research specifically for an 

orchard situation noted that more streptomycin-resistant isolates were cultured from nonsprayed orchards compared to sprayed orchards.10

Opponents of an extension for streptomycin say:

Streptomycin is an antibiotic considered by the World Health Organization to be of critical 

importance to human medicine.11 Streptomycin is used in a way that exposes bacteria in the 

orchard to the antibiotic.12 Current science shows that environmental exposure to antibiotic use 

in the environment is the major cause of development and spread of antibiotic resistance in 

human pathogens.13The spread of antibiotic resistance does not require contact between the 

antibiotic and human pathogens because the major means of spreading antibiotic resistance is 

through the transfer of genes between different bacteria. Uses resulting in low residues 

(subtherapeutic or subinhibitory levels) can create a high health risk.14 Streptomycin resistance 

is evident and expected to grow if urgent use precaution is not exercised.15 Organic production 

should not be contributing to the problem of antibiotic resistance.

3. Antibiotic Resistance

Proponents and opponents of extending the expiration date of streptomycin agree that the core 

issue here is whether there is a risk of enhancing antibiotic resistance in human pathogens. The 

most astute and experienced scientists in this area realize that science and medicine have to 

find a way to co-exist with resistance, including managing reservoirs of resistance in the 

environment and preventing development of new forms of resistance. (Am. Academy of 

Microbiology, 2009).

Proponents of extending the expiration date of streptomycin say:

• Antibiotic-resistant bacteria that are competent phyllosphere colonisers can persist in the 

environment, evidently independent of antibiotic use, as shown by Yashiro and McManus 

(2012). They demonstrated that long-term applications of streptomycin alone did not alter 

the bacterial communities on apple leaves. They sampled leaves from four orchards that 

were treated with spring-time applications of streptomycin over 10 years and from four 

orchards that were not sprayed with antibiotics. The bacterial genera Massilia, 

Methylobacterium, Pantoea, Pseudomonas, and Sphingomonas were detected from all 

orchards, regardless of spray history. More streptomycin-resistant isolates (65%) were 

cultured from non-sprayed orchards compared to sprayed orchards (50%). They concluded 

that factors other than streptomycin influence both the proportion of streptomycin-resistant 

bacteria and phylogenetic makeup of bacterial communities on apple leaves (Yashiro and 

McManus, 2012).

• There are numerous reports that the use of antibiotics in animal production is associated 

with increase of antibiotic-resistant bacteria in animals, waste-water, and manure (for some 

examples see Larsen 2010, Wright 2010). A direct linkage was reported between infection 

and colonization of humans by antibiotic resistant bacteria from farm animals (Larsen et al 

2010). No direct linkage has been demonstrated between antibiotic resistant bacteria in 

humans and antibiotic sprays on plants (Stockwell and Duffy, 2012).

5/186
Opponents of extending the expiration date of streptomycin say:

• Application of streptomycin leads to an increase of streptomycin resistance in the fireblight 

organism and other bacteria in the orchard. 

Selection of bacteria resistant to streptomycin occurs at extremely low antibiotic 

concentrations.16 It is accepted that reliance on streptomycin for fireblight control resulted in the 

development and spread of resistance to streptomycin in E. amylovora.17 Resistance genes are 

prevalent in treated soils,18 and researchers have concluded that resistance is often acquired 

through gene transfer.19 Some researchers found the highest concentration of streptomycinresistant bacteria in the phylloplane of treated crops,20 but Yashiro and McManus (2012)21 found 

a higher percentage of cultured phyllosphere bacteria resistant to streptomycin at non-sprayed 

orchards than at sprayed orchards. But they stated, 

However, our conclusion does not absolve streptomycin of all risk associated with its 

use. For example, it is possible that streptomycin could select for novel resistance genes 

in apple orchards, even if the overall frequency of resistant bacteria is not increased. A 

greater diversity of mobile resistance genes in apple orchards could lead to horizontal 

transfer of resistance among a greater range of bacteria, which in turn could be 

consumed on fresh produce.

• Streptomycin resistance genes from the orchard are transferable to other bacteria.

Streptomycin resistance in E. amylovora may come from a chromosomal or two known 

streptomycin resistance genes carried on plasmids.22 “The carriage of strA-strB within an 

integron, a transposon, and on broad-host-range plasmids has facilitated the world-wide 

dissemination of this determinant among at least 21 bacterial genera.”23 The streptomycin 

resistance genes (strA-strB) are known to be carried on transposons and spread by horizontal 

gene transfer, but are unlikely to have been transferred directly –it is more likely that they are 

spread through intermediate bacteria. “The distribution of the strA-strB genes in the environment 

clearly illustrates the expansiveness of a common microbial gene pool and the rapid 

dissemination of Abr determinants in bacterial populations.” 24 This has been confirmed by a 

several researchers.25

• Streptomycin is a critically important antimicrobial.

Streptomycin is classified as a critically important antimicrobial by the World Health 

Organization. It is a limited therapy as part of treatment of enterococcal endocarditis and MultiDrug Resistant (MDR) tuberculosis.26 It is also effective in treating Brucella (brucellosis), 

Calymmatobacterium granulomatis (donovanosis, granuloma inguinale), Escherichia coli, 

Proteus spp., Aerobacter aerogenes, Klebsiella pneumoniae, and Enterococcus faecalis in 

urinary tract infections, Francisella tularensis, Haemophilus ducreyi (chancroid), Haemophilus 

influenzae (in respiratory, endocardial, and meningeal infections - concomitantly with another 

antibacterial agent), Klebsiella pneumoniae pneumonia (concomitantly with another antibacterial 

agent), Mycobacterium tuberculosis, Pasteurella pestis, Streptococcus viridans, Enterococcus 

faecalis (in endocardial infections - concomitantly with penicillin).27 

4. Ecological Impacts

Opponents of extending the use of streptomycin say:

• Streptomycin use may have unforeseen ecological impacts.

Since resistance to antibiotics is more prevalent in some groups of microorganisms than others, 

the dispersal of streptomycin in the environment can disrupt the microbial ecology. For instance, 

blue-green algae, which are important in sequestering carbon dioxide and releasing oxygen 

gas, are as a group susceptible to antibiotics.28 

Differences between Streptomycin and Oxytetracycline

6/186
•• Use: While tetracycline is only used during bloom and will only be present on fruit that set 

early in the bloom period while the late blooms are being sprayed, streptomycin is registered 

for use from early bloom until 45 days before harvest. 

•• Mode of Action: Streptomycin binds irreversibly to bacterial ribosomes and block synthesis of 

proteins (51). Oxytetracycline binds reversibly to these proteins (McManus et al., 2002). 

(Category 1, Question 9]

•• Mechanism of Resistance: There are 2 mechanisms of resistance to streptomycin in fire 

blight bacteria: spontaneous mutation of a chromosomal gene which encodes production of 

ribosomal protein, thus strep cannot bind to ribosome and bacteria become immune to 

antibiotic. This is most common in the US. Acquired resistance has been detected 

occasionally in MI and CA. The pathogen acquired plasmids that contained genes encoding 

an enzyme that inactivates strep. These resistant isolates of fire blight were detected in an 

orchard ten years after applications were stopped (34). The fire blight bacteria have not 

been known to develop resistance to tetracycline in the laboratory, and little is known about 

the mechanisms for resistance to tetracycline in that bacteria.

** Genetics of Resistance: The genes for resistance to streptomycin that are transferred by 

plasmid are the same genes known to confer resistance to streptomycin in human 

pathogens.29 This is a step in the chain of causation that is not known for tetracycline.

•• Residue on Fruit: While there were not specific studies besides EPA data that set ADI limits 

that showed residue of tetracycline on fruit, one study in Austrian orchards showed detection 

of streptomycin residues (33) in apples, with the highest concentrations in the apple core. 

Apple fruit were collected about three months after bloom and tested for streptomycin. The 

level of detection was 2 μg/kg (0.002 ppm or 2 ppb) and the limit of quantification was 

identified as 7 μg/kg (0.007 ppm or 7 ppb). They reported that the highest concentration of 

streptomycin detected was 18 μg/kg (0.018 ppm), well below the EPA tolerance of 250 

μg/kg (0.25 ppm). The Austrian ADI for streptomycin is 0.03 mg per kg of body mass per 

day (0.03 ppm). The study did not report on exactly what spray practices led to this 

result.)[Category 1, Question 9]

•• Use in medicine: Both tetracycline and streptomycin are classified as critically important 

antimicrobials by the World Health Organization. Tetracycline is one of a limited number of 

therapies for infections due to Brucella, Chlamydia spp. and Rickettsia spp. Streptomycin is 

a Limited therapy as part of treatment of enterococcal endocarditis and Multi-Drug Resistant 

(MDR) tuberculosis. Tetracycline has a higher priority because it is used more frequently for 

specific uses, which could lead to faster spread of resistance. Tetracycline is administered 

orally, while streptomycin is administered by injection.30 It is unclear what link there may be 

between oral ingestion and the build-up of resistance to injected streptomycin.

Conclusions

Those supporting an extension of streptomycin use say:

There is no evidence that applications of antibiotics to orchards during bloom contributes to 

antibiotic-resistance in human pathogens. Human pathogens have not been found in orchards 

and would have to be present for the resistance genes to transfer. Naturally occurring 

streptomycin resistant bacteria may be minor components of the overall bacterial communities 

found on apple flowers and in soils, but their presence is independent of the antibiotic 

application. The amount and timing of the use of this material in an orchard environment does 

7/186
not contribute to any human health concerns, especially in light of streptomycin being ineffective 

in humans when ingested orally.

Those opposing an extension of streptomycin use say:

There is evidence that application of streptomycin leads to increase resistance to streptomycin 

in orchard bacteria, that human pathogens and the fire blight bacteria share the same gene pool 

of genes resistant to streptomycin (i.e., that the same genes responsible for resistance in 

Erwinia amylovora are also responsible for resistance in human pathogens), that human 

pathogens do not need to be present in the orchard to obtain resistance genes acquired by and 

augmented in orchard bacteria, that streptomycin residues are sometimes present in treated 

fruit, and that streptomycin is still a critically important antimicrobial for use against human 

pathogens. In light of the crisis of antibiotic resistance, we cannot allow streptomycin use to be 

extended in organic production.

Evaluation Criteria (see attached checklist for criteria in each category)

 

 Criteria Satisfied? 

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☒ Yes ☐ No ☐ N/A

3. Compatibility & Consistency ☒ Yes ☐ No ☐ N/A 

Substance Fails Criteria Category: NA 

Recommended Subcommittee Action & Vote, including classification recommendation (state 

actual motion):

Classification Motion: Streptomycin is synthetic and is already classified as such on the 

National List so there is no need to make a motion to that effect.

Listing Motion

Motion to remove the existing expiration date of October 21, 2014 for streptomycin at

§205.601(i)(11), and replace it with an expiration date of October 21, 2017, so that the listing 

reads: (11) Streptomycin, for fire blight control in apples and pears only until October 21, 

2017

Motion by: Harold Austin 

Seconded by: Zea Sonnabend

Yes: 5 No: 3 Absent: 0 Abstain: 0 Recuse: 0 

Additional Motion: Resolution: The National Organic Standards Board is committed to the 

phase out of this material. Between now and the expiration date the Board urges growers 

and certifiers to include in organic systems plans an annual increase in the extent and/or 

number of alternative practices and materials that are trialed for controlling fire blight. In 

addition, the board strongly advocates to USDA a high priority for increased support for 

research into these alternative practices and materials.

Motion by: Harold Austin 

Seconded by: Zea Sonnabend

Yes: 8 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

 Approved by Jay Feldman, Subcommittee Chair, to transmit to NOSB August 6, 2013

8/186
NOSB Evaluation Criteria for Substances Added To the National List: Crops 

Category 1. Adverse impacts on humans or the environment? Streptomycin 

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is there a probability of 

environmental contamination 

during use or misuse? 

[§6518(m)(3)]

X X The petition claims the manufacturing process 

as CBI. However, the 2011 TR (lines 314-315) 

states, “Dzhedzhev et al. (1975) reported that 

the manufacture of streptomycin resulted in 

high atmospheric concentrations of the 

solvents butyl alcohol and butyl acetate in the 

workplace.” The TR also says (lines 315-332) 

Streptomycin is produced using fermentation, 

a process that usually involves the use of 

solvents and gases that may be discharged 

into water or air, subject to EPA permits. The 

TR concludes (lines 326-328) that assuming 

streptomycin manufacturers comply with 

applicable water and air regulations; it is 

unlikely that environmental contamination will 

result from the fermentation process. (March 

8, 2011 TR – lines 326-328) also in that same 

TR, lines 334-341 states that no surface 

residue can be found on pear or apple trees 

after four to six weeks following a spray 

application(Gardan and Manceau (1984)). 

Also in this same section the EPA (1988) 

states streptomycin residues are nondetectable (<0.5ppm) on crops when treated 

according to label use rates and directions. 

TR lines 414-415 states that the RED for 

streptomycin concluded that agricultural 

streptomycin products, labeled and used 

according to EPA regulations, will not pose 

unreasonable risks or adverse effects to the 

environment (EPA 1992). There is an EPA 

registration review of streptomycin underway 

that is scheduled to be completed in 2014.

2. Is there a probability of 

environmental contamination 

during, manufacture or disposal? 

[§6518(m)(3)]

X X See above for detailed explanation

3. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

X

4. Is there potential for detrimental 

chemical interaction with other 

materials used in organic farming 

systems?

[§6518(m)(1)]

X Streptomycin should not be applied following 

an application of a Bordeaux mixture and it is 

incompatible with lime sulfur (according to the 

2002 HSDB) (March 8, 2011 TR lines 357 & 

358).

9/186
5. Is there a toxic or other adverse 

action of the material or its 

breakdown products?

[§6518(m)(2)]

XX March 8, 2011 TR (lines 338) states that strep 

breakdowns into products that include 

methylamine, carbon dioxide, and urea, all of 

which occur naturally in the environment. 

(EPA 1988, 1992) EPA cited data that showed 

that streptomycin biodegrades relatively 

quickly in soil and water.

Streptomycin can be phytotoxic to plants; 

therefore it is sprayed on the surface of plants 

rather than injected (McManus and Stockwell, 

2000). Most apple and pear producers are 

prudent in their use of streptomycin sprays to 

reduce costs and to prevent the development 

of streptomycin-resistant strains of Erwinia 

amylovora. Disease risk models help 

producers optimize the timing of antibiotic 

sprays and reduce the total number of 

applications. These measures can help 

reduce the development of antibiotic 

resistance. (March 8, 2011 TR lines 111-115)

There is a high probability that streptomycin 

resistant bacteria are present in the 

environment as a consequence of pesticidal 

use of streptomycin (EPA, 2006a). (TR lines 

429-431) The HED Chapter of the TRED 

states that there have been reports of adverse 

effects resulting from use of streptomycin as a 

pesticide (EPA, 2006a). (TR lines 449-450) 

Because of the risk to workers, personal 

protective equipment is advised to prevent 

skin contact with streptomycin, and workers 

are not permitted re-entry into treated areas 

for at least 12 hours. (TR lines 454-456)

6. Is there persistence or 

concentration of the material or 

breakdown products in the 

environment? [§6518(m)(2)]

XX A certain background level of streptomycin is 

expected in soil due to the natural presence of 

the bacterium Streptomyces griseus (Brosche, 

2010). EPA (1988, 1992) cited data that show 

that streptomycin biodegrades relatively 

quickly in soil and water. (TR lines 207-210). 

The breakdown products include 

methylamine, carbon dioxide, and urea, all of 

which occur naturally in the environment. 

Therefore, the application of streptomycin for 

control of fire blight in apples and in pears in 

accordance with labeled instructions is 

unlikely to contaminate the environment. (TR 

lines 337-341).

According to EPA, streptomycin is moderately 

persistent in aerobic soil (a single value of 

t1/2= 17.5 days was determined). EPI Suite 

estimated a shorter aerobic soil half-life (t1/2= 

25 days) and a longer sediment half-life (t1/2= 

100 days). Given the moderate 

10/186
persistence/high mobility and solubility of 

streptomycin, the chemical is expected to 

dissipate relatively slowly and at the same 

time be vulnerable to leaching/run-off. (TR 

lines 217-225) Gardan and Manceau (1984) 

reported that no surface residue of 

streptomycin was detectable on pear or apple 

trees after four to six weeks following spray 

application. However, Mayerhofer et al. (2009) 

showed that the use of streptomycin sprays 

can lead to detectable concentrations of 

streptomycin in apples. Streptomycin was 

detected in 20 of 41 samples from orchards 

that were treated one to three times with 

streptomycin sprays. The concentration of 

streptomycin was highest in the apple cores 

and skin and ranged from 1.9 to 18.4 μg/kg 

(equivalent to 0.0019 to 0.0184 ppm, well 

below the EPA’s established tolerance of 0.25 

ppm). (TR lines 238-244)

7. Would the use of the substance be 

harmful to human health or the 

environment? [§6517 (c)(1)(A)(i); 

§6517 (c)(2)(A)(i); §6518(m)(4)]

X X The TRED for streptomycin concluded that 

“there is reasonable certainty that no harm to 

any population subgroup will result from 

exposure to streptomycin (EPA, 2006b). 

(March 8, 2011 TR lines 438 – 439) Also, in 

the TR lines 441-444 states that “Current 

tolerances (maximum residue limits) for 

streptomycin on or in apples and pears is 

0.25ppm. Assuming that the maximum 

amount of streptomycin residues are present 

in all types of food which may contain 

residues, EPA determined that chronic 

aggregate dietary exposure from streptomycin 

residues in food and water is not considered 

to be a human health concern (EPA, 2006a).

Bacterial resistance to streptomycin as a 

result of pesticidal use has the potential to 

cause adverse public health consequences if 

human bacterial pathogens are present in 

orchards and develop resistance or if nonpathogenic bacteria in orchards develop 

resistance and later transfer the resistance to 

human bacterial pathogens. EPA’s 

assessment concluded that “the possibility of 

antibiotic resistance resulting in adverse 

human health consequences was of medium 

concern following occupational application 

and was of high concern following application 

by residential users” (EPA, 2006a, pg. 3). (TR 

lines 645-650) Streptomycin remains 

important in modern medicine, and an 

increase in streptomycin-resistant bacteria in 

11/186
the environment and in humans may lead to 

adverse human health consequences. 

Streptomycin is used today in medicine in 

combination therapy to treat tuberculosis (due 

to increasing resistance to other anti-

tubercular drugs) and enterococcal 

endocarditis (when there is resistance to 

gentamicin). It is also used to treat the plague 

and tularemia. (TR lines 634-638)

See also question #5. 

Streptomycin is toxic to algae (Qian et al.,

2012) and therefore the EPA requires a 

warning on any streptomycin label include a 

warning not to apply directly to water or in 

areas where surface water is present, and to 

not contaminate water during cleaning of 

equipment or disposal of wastes. TR lines 

414-415 states that the RED for streptomycin 

concluded that agricultural streptomycin 

products, labeled and used according to EPA 

regulations, will not pose unreasonable risks 

or adverse effects to the environment (EPA 

1992). There is an EPA registration review of 

streptomycin underway that is scheduled to be 

completed in 2014.

8. Are there adverse biological and 

chemical interactions in the agro-

ecosystem, including biodiversity? 

[§6518(m)(5)]

X Toxic to bacteria and algae. See question #7. 

The ammonium-Nitrogen concentration was 

significantly increased following application of 

streptomycin, possibly indicating that nitrifying 

bacteria were susceptible to this bactericide. 

This study also found that application of 

streptomycin at a rate of 3 mg/g soil caused a 

continuing reduction in the total bacterial 

population which lasted longer than the study 

(22 days). Streptomycin applied at 3 mg/g soil 

also reduced active hyphae only on the first 

day following application. A broad-spectrum 

antibiotic like streptomycin would be expected 

to inhibit the nitrification process in soil. The 

presence of streptomycin in three different 

types of soils affected the ecological balance 

in the soil, causing the elimination of some 

bacterial populations. The eliminated species 

were described as beneficial bacteria involved 

in various metabolic processes, mineralization 

of organic compounds, degradation of toxic 

compounds, or creating soil structure. This 

study also isolated from the soils many strains 

of bacteria demonstrating resistance to 

streptomycin, including opportunistic 

pathogens of humans and/or animals. (2011 

TR lines 377-378, 379-382, 386-387, 389-391, 

395-398)

12/186
Based on the limited data available, it is still 

unclear if the use of streptomycin for control of 

fire blight has significant negative effects on 

interactions in the agro-ecosystem, including 

soil organisms. There are no studies available 

in the field and the studies in the laboratory 

with soil bacterial populations appear to be 

contradictory. (TR lines 404-407)

9. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518(m)(5)]

X Toxic to algae. (TR line 347) Algae are 

present in most of the soils where moisture 

and sunlight are available, mostly blue-green 

(Cyanophyta) and green (Chlorophyta). Soil 

algae are important in maintaining fertility, 

building soil organic matter, building soil 

structure, increasing water holding capacity, 

and aerating soils.31

Category 2. Is the Substance Essential for Organic Production? Streptomycin

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? 

[§6502(1)]

X

2. Is the substance formulated or 

manufactured by a chemical 

process? [§6502(21)]

X

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral sources? 

[§6502(21)]

X Streptomycin is a naturally occurring 

compound which is produced by the soil 

bacterium Streptomyces griseus.

Agricultural streptomycin is produced on a 

large scale by aerobic fermentation of 

Streptomyces griseus followed by isolation 

and purification by ion exchange (HSDB, 

2002; EPA, 1992) March 8, 2011 TR lines 

172-174. Also, TR lines 199-200 states that 

Streptomycin is produced through a 

naturally occurring process (aerobic 

fermentation), but the processes used to 

isolate and purify the substance are not 

naturally occurring. The forms of 

streptomycin currently on the National List 

as approved are listed as synthetic 

substances.

4. Is the substance created by 

naturally occurring biological 

processes? [§6502(21)]

X X Streptomycin is a naturally occurring 

compound which is produced by the soil 

bacterium Streptomyces griseus. 

Commercially, streptomycin is produced 

through a naturally occurring process 

(aerobic fermentation), but the processes 

used to isolate and purify the substance are 

not naturally occurring. (TR lines 199-201)

13/186
5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X

6. Is there an organic substitute? 

[§205.600(b)(1)]

X

7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)] 

XX There are several biological control agents 

(such as bacteria or yeast) that are used to 

try to outcompete the fire blight pathogen 

where it occurs on the blossom. These 

materials are used for fire blight 

suppression. Two strains of beneficial 

bacterium, Pantoea agglomerans, are: 

Bloomtime Biological and Blight Ban C9-1. 

The bacterium Pseudomonas fluorescens 

A506 is marketed as Blight Ban A506. There 

are two strains of yeast Aureobasidium 

pullulans that are used to make up the 

product Blossom Protect (Bio-ferm, 

Germany) which has recently been 

introduced into the market to help in 

controlling fire blight. TR 2011 lines 468-

486. In this same TR, Blight Ban A506 is 

rated as being poor to fair for effectiveness, 

lines 493-505 (Johnson et al.,2009) in 

inoculated trials and slightly better in field 

trials (Johnson 2010). Johnson further states 

that Bloomtime and Blight Ban C9-1 both 

performed slightly better with about 50% 

reduction in disease incidence observed in 

the inoculated field tests. He rates 

Bloomtime Biological as poor to good and 

the effectiveness of Serenade Max and 

Blossom Protect as fair to good for 

effectiveness for fire blight suppression. By 

comparison, the antibiotic treatment 

oxytetracycline is described as fair to very 

good, and treatment with streptomycin is 

poor to excellent (the poor rating is due to 

widespread pathogen resistance to 

streptomycin within the western states). (TR 

lines 493-507) Disease control was more 

consistent in field trials conducted with 

compatible mixtures of antagonistic 

organisms than with single strains –up to 68 

and 71% disease reduction on average, 

compared to 39% and 81% on average, for 

oxytetracycline and streptomycin, 

respectively. (TR lines 517-532) In 

Germany, treatment with Blossom Protect 

resulted in an average efficiency of 82% 

reduction in fire blight incidence (results 

from six different trials). (TR lines 547-548) 

Johnson (2010) reports that he and his 

colleagues evaluated Blossom Protect in an 

14/186
inoculated fire blight trial in 2008 (also using 

four applications during bloom). They found 

this product to be nearly as effective as 

streptomycin (Agri-Mycin) in an orchard with 

high disease pressure. (TR lines 552-555) A 

large amount of public comment received in 

written form to FR Docket AMS-NOP-12-

0070 and verbally at the Spring 2013 

meeting indicated that the above "substitute 

products" did not work well in certain regions 

or agricultural systems and therefore were 

not true substitutes.

8. Are there any alternative 

substances? 

[§6518(m)(6)]

X Besides the biologicals, there are 

alternative substances that are listed as 

having some control of fire blight and of 

these oxytetracycline is by far the best 

alternative substance. Other materials listed 

are various copper mixtures (a couple of 

new products currently being looked at by 

researchers), lime-sulfur, and Peracetic acid 

(which is as a disinfectant and not as a 

spray replacement material).

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)]

XX No one practice can eliminate fire blight, 

including the use of antibiotics. There are 

practices that can help in reducing fire blight 

potential in an orchard as part of a systems 

approach. Some of these would include 

using fire blight prediction models to assist 

in proper timing of materials applications, 

monitoring and removal of infected plant 

tissue, planting of resistant root stocks (this 

would only protect the root system and not 

the fruit producing portion of the tree), 

ground cover and water management to 

help reduce humidity levels within an 

orchard, and also planting of more fire blight 

resistant cultivars. (TR lines 601-617, 671-

701)

15/186
Category 3. Is the substance compatible with organic production practices? Streptomycin 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)] 

X X It is currently included on the National List 

of Allowed and Prohibited Substances, as 

a synthetic substance allowed in organic 

crop production for fire blight control in 

apples and pears only [7 CFR 205.601 

(i)(11)] as previously /currently 

approved by the NOSB and implemented 

into policy by the NOP. Contrary to 

consumer expectations. Inconsistent with 

prohibition on antibiotics in livestock. 

Inconsistent with European requirements.

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

X X If it is used as part of an organic systems 

plan in a rotational manner, to enhance 

resistance management in an effort to 

minimize the potential for resistance to 

fire blight to develop.

Increases likelihood of antibiotic 

resistance in pathogenic organisms. It is 

not sustainable because the fire blight 

organism will develop resistance.

3. If used in livestock feed or pet food, Is 

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X

4. If used in livestock feed or pet food, Is 

the primary use as a preservative? 

[§205.600(b)(4)]

X

5. If used in livestock feed or pet food, Is 

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)]

X

6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories: 

[§6517(c)(1)(B)(i); 

copper and sulfur compounds

X

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X

livestock parasiticides and medicines X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X

16/186
1 Stockwell, V.O., and Duffy, B., 2012. Use of antibiotics in plant agriculture. Rev. Sci. Tech. Off. Int. 

Epiz., 31:199-210.

2 As reported in Ostenson, H.T. 2010. Organic pome and cherry production and marketing issues: Past, 

present and future. Acta Hort. (ISHS) 873:137-144, and presented to IFOAM, “Over the last ten years, the 

Hartman Group (Bellevue, Washington, USA) has studied changes in consumer attitudes, backgrounds, 

and buying characteristics related to the organic market. The Hartman Group surveyed about two 

thousand household consumers across four regions of the USA. They found that the ‘traditional’ 

properties suggested by ‘organic’ were no longer the same properties held by the new organic consumer. 

The survey indicated that traditional properties such as ‘locally-grown,’ Fair Trade, ‘tastes better,’ and 

sustainable production ranked at the bottom. The new organic consumers made it clear that they want, 

plain and simple, a product centered around the ‘absence of all health concerns,’ and the absence of 

pesticides, growth hormones, GMO’s, antibiotics, and BSE.”

3 McGhee, G. C., Guasco, J., Bellomo, L. M., Blumer-Schuette, S. E., Shane, W. W., Irish-Brown, A., and 

Sundin, G. W., 2011. Genetic analysis of streptomycin-resistant (SmR) strains of Erwinia amylovora 

suggests that dissemination of two genotypes is responsible for the current distribution of SmR E. 

amylovora in Michigan. Phytopathology 101:182- 191.

4 Russo, N. L., Burr, T. J., Breth, D. I., and Aldwinckle, H. S., 2008. Isolation of streptomycin resistant 

isolates of Erwinia amylovora in New York. Plant Dis. 92:714-718.

5 Claudia Nischwitz, Christine Dhiman, 2012. Streptomycin resistance of Erwinia amylovora, causal 

agent of fire blight. Utah State University Extension and Utah Plant Pest Diagnostic Laboratory, PLP-018.

6 McGhee, G. C., Guasco, J., Bellomo, L. M., Blumer-Schuette, S. E., Shane, W. W., Irish-Brown, A., and 

Sundin, G. W. 2011. Genetic analysis of streptomycin-resistant (SmR) strains of Erwinia amylovora 

suggests that dissemination of two genotypes is responsible for the current distribution of SmR E. 

amylovora in Michigan. Phytopathology 101:182- 191.

7 Russo, N. L., Burr, T. J., Breth, D. I., and Aldwinckle, H. S., 2008. Isolation of streptomycin resistant 

isolates of Erwinia amylovora in New York. Plant Dis. 92:714-718.

8

Instead, these growers rely on a number of other practices, allowing them to avoid fire blight damage to 

susceptible varieties. Balancing nutrients and avoiding over-application of nitrogen fertilizers, especially 

on susceptible varieties of apples or pears; avoidance of over-pruning in the dormant season; use of prebloom foliar nutrient sprays even though there is no foliage; use of copper materials on the trees between 

delayed dormant and tight cluster sages as preventive measures against overwintering FB; use of lime 

sulfur during bloom to thin apples; and, use of Serenade MAX (in the future, perhaps Blossom Protect) 

post-bloom and at petal-fall, with good spray coverage. (With some differences for pears.) 9 In response, the following is suggested: Increase species diversity; decrease tree density; use resistant 

cultivars and rootstocks; plant a variety of cultivars on a variety of rootstocks.

10 Yashiro, E & McManus, P. 2012 Effect of streptomycin treatment on bacterial community structure in 

the apple phyllosphere. PLoS ONE 7(5): e37131. doi:10.1371/journal.pone.0037131

11 WHO, 2009. Critically Important Antimicrobials for Human Medicine, 

http://www.who.int/foodsafety/foodborne_disease/CIA_2nd_rev_2009.pdf See Table 1.

12 Streptomycin TR, 2011. Lines 423-431.

13 American Academy of Microbiology, 2009. Antibiotic Resistance: An Ecological Perspective on an Old 

Problem. http://academy.asm.org/images/stories/documents/antibioticresistance.pdf (pp.1-5, 10.) 14 American Academy of Microbiology, 2009. (p.8.) 15 Streptomycin TR, 2011. Lines 632-633. American Academy of Microbiology, 2009. (p.2.) 16 Gullberg E, Cao S, Berg OG, Ilbäck C, Sandegren L, et al., 2011. Selection of Resistant Bacteria at 

Very Low Antibiotic Concentrations. PLoS Pathog 7(7): 1-9.

17 McGhee, G. C., Guasco, J., Bellomo, L. M., Blumer-Schuette, S. E., Shane, W. W., Irish-Brown, A., and 

Sundin, G. W. 2011. Genetic analysis of streptomycin-resistant (SmR) strains of Erwinia amylovora 

suggests that dissemination of two genotypes is responsible for the current distribution of SmR E. 

amylovora in Michigan. Phytopathology 101:182-191. Alan L. Jones and Elise L. Schnabel, 2000. The 

Development of Streptomycin-resistant Strains of Erwinia amylovora, in J.L. Vanneste (ed.), Fire Blight 

The Disease and its Causative Agent, Erwinia amylovora, CAB International, UK. Pp. 235-254.

18 S. Tolba et al., 2002. Distribution of streptomycin resistance and biosynthesis genes in streptomycetes 

recovered from different soil sites. FEMS Microbiology Ecology 42: 269-276

17/186
19 Egan, S., Wiener, P., Kalli¢das, D. and Wellington, E.M.H. (2001) Phylogeny of Streptomyces species 

and evidence of horizontal transfer of entire and partial antibiotic gene clusters. Antonie Van 

Leeuwenhoek 79, 127-133. Wiener, P., Egan, S. and Wellington, E.M.H. (1998) Evidence of transfer of 

antibiotic-resistance genes in soil populations of streptomycetes. Mol. Ecol. 7, 1205-1216.

20 George W. Sundin, Dave E. Monks, Carol L. Bender, 1995. Distribution of the streptomycin-resistance 

transposon Tn5393 among phylloplane and soil bacteria from managed agricultural habitats. Canadian 

Journal of Microbiology, 41(9): 792-799.

21 Yashiro E, McManus PS, 2012. Effect of Streptomycin Treatment on Bacterial Community Structure in 

the Apple Phyllosphere. PLoS ONE 7(5): e37131

22 McGhee, G. C., Guasco, J., Bellomo, L. M., Blumer-Schuette, S. E., Shane, W. W., Irish-Brown, A., and 

Sundin, G. W. 2011. Genetic analysis of streptomycin-resistant (SmR) strains of Erwinia amylovora 

suggests that dissemination of two genotypes is responsible for the current distribution of SmR E. 

amylovora in Michigan. Phytopathology 101:182- 191.

23 Sundin, G. W. 2002. Distinct recent lineages of the strA-strB streptomycin-resistance genes in clinical 

and environmental bacteria. Curr.Microbiol. 45:63-69.

24 GW Sundin and CL Bender, 1996. Dissemination of the strA-strB streptomycin-resistance genes 

among commensal and pathogenic bacteria from humans, animals, and plants, Molecular Ecology 5, 

133-143

25 See for example, Cristina Pezzella, Antonia Ricci, Elisabetta DiGiannatale, Ida Luzzi, and Alessandra 

Carattoli, 2004. Tetracycline and Streptomycin Resistance Genes, Transposons, and Plasmids in 

Salmonella enterica Isolates from Animals in Italy. Antimicrobial Agents and Chemotherapy, 48 (3): 903–

908. Alexandre Scherer, Hans-Rudolf Vogt, Edy M. Vilei, Joachim Frey, and Vincent Perreten, 2013. 

Enhanced antibiotic multi-resistance in nasal and faecal bacteria after agricultural use of streptomycin, 

Environmental Microbiology 15(1), 297–304. (“This study shows that the application of low concentrations 

of streptomycin on grass, as occurs during the spraying of orchards, selects for multidrug-resistant nasal 

and enteric bacterial flora, including extended-spectrum beta-lactamase-producing E. coli.”) Foster, G. C., 

McGhee, G. C., Jones, A. L., and Sundin, G. W. 2004. Nucleotide sequences, genetic organization, and 

distribution of pEU30 and pEL60 from Erwinia amylovora. Appl. Environ. Microbiol. 70:7539-7544.

26 WHO, 2009. Critically Important Antimicrobials for Human Medicine, 

http://www.who.int/foodsafety/foodborne_disease/CIA_2nd_rev_2009.pdf See Table 1. Tuberculosis is 

rapidly developing resistance to all known antimicrobials. Phillip Trollip, 2013. Emergence and Spread of 

Extensively and Totally Drug-Resistant Tuberculosis, South Africa. Emerging Infectious Diseases, 19 (3): 

449-455 www.cdc.gov/eid 27 http://www.drugs.com/pro/streptomycin.html 28 Jose Luis Martinez, 2009. Environmental pollution by antibiotics and by antibiotic resistance 

determinants. Environmental Pollution 157: 2893–2902.

29 See, for example, the following articles. C.-S. Chiou and A. L. Jones, 1993. Nucleotide Sequence 

Analysis of a Transposon (Tn5393) Carrying Streptomycin Resistance Genes in Erwinia amylovora and 

Other Gram-Negative Bacteria. Journal of Bacteriology, Vol. 175, (3): 732-740. GW Sundin and CL 

Bender, 1996. Dissemination of the strA-strB streptomycin-resistance genes among commensal and 

pathogenic bacteria from humans, animals, and plants, Molecular Ecology 5, 133-143. McGhee, G. C., 

and Sundin, G. W. 2011. Evaluation of kasugamycin for fire blight management, effect on nontarget 

bacteria, and assessment of kasugamycin resistance potential in Erwinia amylovora. Phytopathology 

101:192-204. Cristina Pezzella, Antonia Ricci, Elisabetta DiGiannatale, Ida Luzzi, and Alessandra 

Carattoli, 2004. Tetracycline and Streptomycin Resistance Genes, Transposons, and Plasmids in 

Salmonella enterica Isolates from Animals in Italy. Antimicrobial Agents and Chemotherapy, 48 (3): 903–

908. Alexandre Scherer, Hans-Rudolf Vogt, Edy M. Vilei, Joachim Frey, and Vincent Perreten, 2013. 

Enhanced antibiotic multi-resistance in nasal and faecal bacteria after agricultural use of streptomycin, 

Environmental Microbiology 15(1), 297–304.

30 WHO, 2009. Critically Important Antimicrobials for Human Medicine, 

http://www.who.int/foodsafety/foodborne_disease/CIA_2nd_rev_2009.pdf See Table 1. 

31 “Soil microorganism—algae” My Agriculture Information Bank 

http://agriinfo.in/?page=topic&superid=5&topicid=150 

Zancan, S., Trevisan, R., & Paoletti, M. G. (2006). Soil algae composition under different agroecosystems in North-Eastern Italy. Agriculture, ecosystems & environment, 112(1), 1-12.

18/186
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Magnesium Oxide

August 6, 2013

*Revised February 26, 2014 - Minority opinion added

Summary of Proposed Action:

 

Magnesium oxide (MgO) has been petitioned for use under §205.601 Synthetic substances 

allowed for use in organic crop production. Specifically, the petition states “Magnesium oxide is 

intended to be used to control the viscosity of a clay suspension agent to prevent settling of 

materials suspended in water or other liquids.” The petitioner indicates they wish to use MgO 

for the application of finely ground humates, but the petition is written more broadly: “The 

substance is intended to be used in combination with other organic inputs applied as a liquid 

foliar on a wide variety of different agricultural, vegetable, fruit, and horticultural crops.”

The petitioner indicates they would use MgO at a very low level: at 0.074% of the humate 

suspension being applied, which would equate to 0.0007 to 0.0014 pounds of MgO applied per 

acre.

Magnesium oxide occurs as the mineral magnesia, and in its hydrated form – magnesium 

hydroxide -- is the naturally occurring mineral periclase. Magnesium oxide appears to be a fairly 

benign compound that has a wide range of uses, including as an antacid and laxative (milk of 

magnesia), and in lots of industrial processes such as in producing cement, abrasive materials 

and furnace linings. 

There are several manufacturing processes used to produce MgO. It is commonly made from 

sea water or salt brines, but can also be made by heating MgCO3 limestone to drive off CO2 and 

produce MgO. (To produce MgO from sea water or salt brine uses the following procedure: The 

raw materials are lime and salt water -- either sea water or brine from salty wells. The lime is 

heated to produce calcium oxide. Fresh water is then added to the calcium oxide to produce 

calcium hydroxide. Sea water or salt brine from a well -- treated with a small amount of sulfuric 

or hydrochloric acid -- is then added to the calcium hydroxide, causing the magnesium chloride 

in the salt water to react with calcium hydroxide to produce magnesium hydroxide and calcium 

chloride. The magnesium hydroxide is then heated to produce magnesium oxide.)

The MgO manufactured using sea water or salt brine (and some acid) produces a purer and 

more refined form of MgO than that produced by heating magnesium carbonate limestone, and 

so is preferred by the petitioner. 

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☒ Yes ☐ No ☐ N/A

3. Compatibility & Consistency ☒ Yes ☐ No ☐ N/A 

19/186
Subcommittee Action & Vote: 

Classification Motion: 

Motion to classify Magnesium Oxide as petitioned as synthetic. 

Motion by: Francis Thicke 

Seconded by: Colehour Bondera 

Yes: 8 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

Listing Motion: 

Motion to list Magnesium Oxide at §205.601 with the following annotation: For use only to 

control the viscosity of a clay suspension agent for humates.

Motion by: Francis Thicke 

Seconded by: Zea Sonnabend 

Yes: 8 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

 Basis for annotation: ☒ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

 Approved by Jay Feldman, Subcommittee Chair, to transmit to NOSB August 6, 2013

Minority position: During Subcommittee discussions in January and February 2014, a member

of the Crops Subcommittee made a motion for the following: To list Magnesium Oxide at

§205.601 with the following annotation: Until May 1, 2019 [or 5 years after the date it is first 

allowed]. The motion did not pass. The justification for the minority opinion is as follows: A 

synthetic material used in organic production, even if used in small quantities, must meet all of 

the OFPA criteria. Current consideration of the material has raised issues relating to 

environmental impacts and alternatives. (1) The review in 5 years must be performed with the 

same standard for allowing continued use as is used to approve use in the first place; (2) the 

need for liquid humates and hence MgO should be re-evaluated; (3) the possibility of using 

nonsynthetic acids in place of synthetic sulfuric acid must be re-evaluated.

Approved by Zea Sonnabend, Subcommittee Chair, to transmit to NOSB February 26, 

2014

20/186
NOSB Evaluation Criteria for Substances Added To the National List: Crops

Category 1. Adverse impacts on humans or the environment? Magnesium Oxide

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

X

2. Is there a probability of environmental 

contamination during manufacture or 

disposal? [§6518(m)(3)]

X 

When MgO is produced using sea water 

or salt brine, a small amount of acid is 

used to lower the pH of the salt solution 

to prevent the formation of carbonates.

When MgO is produced using

magnesium carbonate limestone, carbon 

dioxide is released into the atmosphere.

Additional carbon dioxide is produced 

through the burning of fossil fuels used to 

achieve the high heat required to 

decompose the limestone.

3. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)] 

X 

4. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)]

X 

5. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518(m)(2)]

X 

6. Is there persistence or concentration of 

the material or breakdown products in 

the environment? [§6518(m)(2)]

X

7. Would the use of the substance be 

harmful to human health or the 

environment? [§6517 (c)(1)(A)(i); §6517 

(c)(2)(A)(i); §6518(m)(4)]

X

8. Are there adverse biological and 

chemical interactions in the agroecosystem, including biodiversity? 

[§6518(m)(5)]

X 

9. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518(m)(5)]

X 

21/186
NOSB Evaluation Criteria for Substances Added To the National List: Crops 

Category 2. Is the Substance Essential for Organic Production? Magnesium Oxide

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X 

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

X 

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X 

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)] X

.

6. Is there an organic substitute? 

[§205.600(b)(1)] X

7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)]

X

8. Are there any alternative substances? 

[§6518(m)(6)]

X None that have the desired functional 

properties, according to the petitioner. 

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)] 

X MgO is not absolutely essential for the 

materials application it is petitioned for, but it 

makes application easier, and perhaps safer 

for the person applying the materials (reduces 

dust).

Category 3. Is the substance compatible with organic production practices? Magnesium Oxide 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

X 

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

X 

3. If used in livestock feed or pet food, is

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X 

4. If used in livestock feed or pet food, is

the primary use as a preservative? 

[§205.600(b)(4)]

X 

22/186
5. If used in livestock feed or pet food, is

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)]

X 

6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories:

[§6517(c)(1)(B)(i)]; 

copper and sulfur compounds

X 

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X 

livestock parasiticides and medicines X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X

23/186
24/186
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Vinasse

+February 25, 2014

Introduction

The NOSB received a petition for Vinasse as a synthetic soil amendment and plant nutrient 

(fertilizer) for organic crop production. In effect, the petition seeks to have the NOSB classify 

vinasse as a non-synthetic (natural).Petitioning as a synthetic is the only way to achieve a vote 

from the NOSB on this matter.

A limited scope Technical Review was conducted solely on the manufacturing process and 

whether vinasse is synthetic or non-synthetic.

Background

The path to vinasse production is complex, starting with sugar refining, passing through 

molasses fermentation, and ending with multiple distillations. Both sugar and molasses have 

historically been considered non-synthetic and allowed in organic production. From the TR:

44-45. Vinasse is generally obtained through distillation of fermented cane and beet molasses, 

which is a byproduct of cane and beet juice processing for the production of pure or refined 

sugar.

48. Sulfur dioxide is sometimes added during the processing of beet juice prior to crystallization to 

decolorize the cane juice.

51. The resulting byproduct, molasses, is then mixed with yeast or other microorganisms and 

fermented.

54-57. In the case of ethanol production, small amounts of sulfuric acid may be added prior to 

fermentation to reduce the populations and activity of undesired bacterial species by adjusting the 

pH to between 4 and 5. Distillation of the resulting fermentation broth separates the desired 

organic compounds (e.g., ethanol) from the mother liquor. Vinasse is the byproduct of the 

distillation procedure.

The TR goes on to describe in detail the processes for removing the sugar from sugar cane and 

beets, separating the molasses, and then fermenting it to make ethanol with vinasse as a byproduct. Further information from the TR states:

365-377. Molasses is generally less contaminated with bacterial flora than cane juice, as a large 

portion of the non-sporulated bacteria is destroyed during sugar production. Notwithstanding, 

most components are frequently subjected to bacteriostatic or sterilizing thermal (steam) 

treatments to control any bacterial flora that may otherwise excrete undesired organic compounds 

into the fermentation medium (Fahrasmane, 1998). The molasses-based fermentation medium 

may also be treated with small quantities (~0.3 mg/L) of antibiotics, such as penicillin (Borzani, 

1957) and tetracycline (Aquarone, 1960). However, the extent of this practice in current rummaking operations is uncertain. If added, it is possible that these antibiotics will not be fully 

degraded during the fermentation and ethanol distillation processes; a certain amount could 

remain in vinasse derived from antibiotic-treated fermentation mediums. Bacteriosides such as 

chlorine dioxide (Sumner 2011), ammonium bifluoride or quaternary ammonium compounds may 

also be used to control bacterial contamination (Murtagh, 1999). With the exception of chlorine 

dioxide, residues of these compounds may persist in vinasse. Finally, acidification of the media to 

a lower pH (i.e., pH = 4–5) using sulfuric acid generally precedes the fermentation step as a 

protective measure (Fahrasmane, 1998).

25/186
Discussion

The Crops subcommittee reviewed the manufacturing process against the draft guidance on 

classification of materials (NOP 5033). Some of the relevant considerations from the draft 

guidance are:

1) whether the manufacturing process for vinasse is a synthetic or a biological process

2) whether vinasse contains a synthetic substance, not on the National List, at a 

significant level.

3) whether vinasse is the result of a chemical change

4) whether all non-allowed synthetics have been removed to the degree that they have 

no technical or functional effect in the final product. 

It is apparent although not explicitly stated in the TR that vinasse production is decentralized in 

many countries and with many different approaches to the substance during and after 

fermentation. Some vinasse is generated without synthetic materials added during and after 

fermentation, while some may have additional acid, synthetic anti-microbial agents, or even 

synthetic sources of nitrogen added after fermentation. Therefore the subcommittee has 

concluded that since not all vinasse is synthetic, it does not belong on the National List. 

However, the subcommittee also believes that vinasse with synthetic materials added to it after 

fermentation should not be permitted in organic cropping systems. Therefore we are proposing 

specific language for a listing of vinasse in the Guidance on Materials for Organic Crops 

Production (NOP 5034-1). This annotation in the guidance would enable materials review 

organizations to determine those sources that would not be allowed. This annotation is similar, 

but slightly different from, the one on the molasses listing:

Vinasse - may not contain prohibited additives, such as but not limited to, pH adjusters, 

sanitizers, ammonium compounds, antibiotics or chlorine materials that are not provided 

for at §205.601. Nitrogen levels may not be fortified. 

Minority Opinion

Identifying the allowed and prohibited formulations of vinasse through the National List process 

is the appropriate action for the NOSB. The minority proposes to create a hybrid listing on both 

601 and 602, explaining in the recommendation that vinasse is available in both synthetic and 

nonsynthetic forms, but the restrictions that the NOSB recommends is placed on its use apply to 

both forms.   

On 601, list vinasse as synthetic with the following annotation:" Vinasse is only allowed when its 

manufacturing process does not result in synthetic additives, such as, but not limited to, pH 

adjusters, sanitizers, ammonium compounds, antibiotics or chlorine materials, in the formulation 

that are not specifically provided for at 205.601. Nitrogen levels may not be fortified. Vinasse 

may not be produced using genetically engineered microorganisms, sugar beets, or other 

substrate. If the condition on genetically engineered organisms is covered by a general policy 

adopted by the NOSB and codified into regulations, then that language will supersede this 

restriction.” See nonsynthetic versions of vinasse manufactured without synthetic chemical 

change and above substances in 602. The recommendation should explain that the annotation 

is added because there are numerous formulations of vinasse that are synthetic and 

incompatible with organic production.  

26/186
On 602: List vinasse with the following annotation: “Vinasse may not be manufactured with a

process that effects synthetic chemical change or utilizes in synthetic additives, such as, but not 

limited to, pH adjusters, sanitizers, ammonium compounds, antibiotics or chlorine materials, in 

the formulation that are not specifically provided for at 205.601. Nitrogen levels may not be 

fortified. Vinasse may not be produced using genetically engineered microorganisms, sugar 

beets, or other substrate. If the condition on genetically engineered organisms is covered by a 

general policy adopted by the NOSB and codified into regulations, then that language will 

supersede this restriction.”

Subcommittee Action & Vote

Classification Motion: 

Motion to classify Vinasse as non-synthetic

Motion by: Zea Sonnabend 

Seconded by: John Foster

Yes: 4 No: 3 Absent: 0 Abstain: 0 Recuse: 0 

 

Motion: 

Motion to add the following specific language to the listing of vinasse in the Guidance on 

Materials for Organic Crops Production (NOP 5034-1). Vinasse - may not contain prohibited 

additives, such as but not limited to, pH adjusters, sanitizers, ammonium compounds, 

antibiotics or chlorine materials that are not provided for at §205.601. Nitrogen levels may 

not be fortified

Motion by: Zea Sonnabend 

Seconded by: Harold Austin

Yes: 4 No: 3 Absent: 0 Abstain: 0 Recuse: 0 

Approved by Zea Sonnabend, Subcommittee Chair, to transmit to NOSB February 26, 

2014

27/186
28/186
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Laminarin

+February 26, 2014

Introduction

The NOSB received a petition for Laminarin, a seaweed extract for disease control that is 

allowed by EPA for that purpose. 

Background

From the Laminarin petition:

5. The source of the substance and a detailed description of its manufacturing or 

processing procedures from the basic component(s) to the final product.

Stage 1: Fresh Laminaria digitata seaweed, harvested on the North Brittany coast of France, 

undergoes extraction in tap water that has a pH adjusted to 2 by addition of sulfuric acid. At this 

stage sulphuric acid is a processing aid. Laminarin can be extracted at neutral pH or in acidic 

conditions. The described acidic conditions do not modify the chemical structure of laminarin. 

The addition of sulfuric acid avoids the co-extraction of other compounds such as alginates 

(which occurs at neutral pH). When alginates are extracted, the solution has a higher viscosity; 

purification and filtration steps for laminarin then become much more difficult. This is the reason 

why sulphuric acid is used to lower the pH and to facilitate the manufacturing process.

Stage 2: The extract is then filtered using a Seitz filter.

Stage 3: The solution then undergoes tangential filtration (membrane technology – physical 

process) to remove impurities from the solution. The filtrate containing laminarin is kept for the 

next purification step and the retentate is removed.

Stage 4: The filtrate (see above) then undergoes a second tangential filtration to remove any 

remaining impurities (filtrate), thereby resulting in a purified solution of laminarin in water 

(retentate).

Stage 5: The pH is adjusted between 6 and 7 by adding sodium hydroxide to neutralize the 

acidic solution, resulting in a solution of laminarin at neutral pH for formulation purposes (i.e., 

Vacciplant formulation). The addition of dilute sodium hydroxide does not modify the chemical 

structure of laminarin.

From the note from NOP to Crops Subcommittee, 6/3/13:

In NOP’s review of the eligibility of this petitioned substance for the National List, we reviewed 

the manufacturing process against the draft guidance on classification of materials (NOP 5033). 

Based on our preliminary review, this substance may be classified as nonsynthetic. We have 

moved this petition forward for NOSB review and final determination on the classification status 

for the following reasons:

o The classification guidance is currently in draft form

o Other aquatic plant extracts are classified as synthetic for crop production at 

205.601(j)(1)

o At this time, NOP is not aware of any products containing laminarin as an 

active ingredient that are approved by certifying agents or third-party 

material review organizations, such as EPA or OMRI

Discussion

29/186
The Crops subcommittee also reviewed the manufacturing process against the draft guidance 

on classification of materials (NOP 5033, section 4.6): 

4.6 Extraction of Nonorganic Materials

Some materials are produced using manufacturing processes that involve separation 

techniques, such as the steam distillation of oil from plant leaves. Separation and 

extraction methods may include, but are not limited to, distillation, solvent extraction, acidbase extraction, and physical or mechanical methods (e.g., filtration, crushing, 

centrifugation, or gravity separation).

For purposes of classification of a material as synthetic or nonsynthetic, a material may be 

classified as nonsynthetic (natural) if the extraction or separation technique results in a 

material that meets the following criteria:

• At the end of the extraction process, the material has not been transformed into a 

different substance via chemical change; 

• The material has not been altered into a form that does not occur in nature; and 

• Any synthetic materials used to separate, isolate, or extract the substance have 

been removed from the final substance (e.g., via evaporation, distillation, 

precipitation, or other means) such that they have no technical or functional effect 

in the final product.

The majority of the subcommittee has determined that Laminarin is extracted by an acid-base 

extraction and meets the criteria in section 4.6 above.

In regards to the third bullet point above the subcommittee majority believes that the acid-base 

reaction itself neutralizes any of the sulfuric acid starting material to the degree that it has no 

technical or functional effect. The minority opinion tries to draw parallels between laminarin 

which is extracted and then used to boost the plant's immune defenses against disease with 

sulfuric acid used to stabilize manure (a petition that was rejected) or acids used to stabilize fish 

products listed on §205.601. The majority feels these comparisons are not relevant because of 

the acid being used in substantially greater quantities in manure and fish, and the fact that they 

are both fertilizers means that the residual sulfates or phosphates would have a functional effect

in the fertilizers. Laminarin is used for disease control at a rate of 0.52 - 1.04 fl. oz. per acre (as 

stated in the petition) which would not provide a functional effect from some parts per million of 

that rate being sulfate.

Because of a determination that it is non-synthetic, the subcommittee has not filled out a 

checklist as it does not need to be added to the National List.

Minority Opinion

A minority of the Subcommittee supported the view that laminarin is synthetic because sulfuric 

acid is added but not removed. Sodium hydroxide is added to neutralize sulfuric acid, but the 

sodium sulfate produced by the neutralization reaction (which does not chemically change 

laminarin) is not removed.

The minority agrees that laminarin does not undergo chemical change in the extraction process. 

Unfortunately, however, the NOP decision tree is incomplete –it does not cover all of the criteria 

in the guidance document NOP 5033. The guidance document states, “Some materials may be 

considered synthetic due to chemical changes which occur during manufacturing, while others 

substances may be classified as synthetic due to addition of small amounts of synthetic 

ingredients.”

30/186
In the case of laminarin, we need to look at the synthetic ingredients that are added. The section 

on extraction in the NOP guidance states that in order for a material to by classified as 

nonsynthetic, “Any synthetic materials used to separate, isolate, or extract the substance have 

been removed from the final substance (e.g., via evaporation, distillation, precipitation, or other 

means) such that they have no technical or functional effect in the final product.”

 

The extraction of laminarin involves the addition of sulfuric acid, as described in the petition. The 

sulfuric acid is not removed. Sodium hydroxide is added to neutralize the acid, but the sulfate 

remains. While there is no definition of “technical or functional effect” in the NOP regulations or 

the guidance, our calculations suggest that the amount of sulfate and sodium added to laminarin 

in the extraction process is significant.

The minority does not claim that the sulfate in laminarin constitutes a synthetic plant nutrient 

because it is not used in quantities that would be significant nutritionally to plants. Rather, the 

claim is that the sulfate is a significant residue within the laminarin that is not removed.

Some relevant points that we considered: 

1. Sulfuric acid is added during the extraction of laminarin to reduce the pH to 2. Later, it is 

neutralized with the addition of the base sodium hydroxide. Although the sulfuric acid is 

neutralized, it is not removed. We calculate that altogether, 624 parts per million (ppm) 

sulfate and 299 ppm of sodium are added.1 Because the kelp provides some (unknown) 

buffering capacity, the quantities are probably somewhat higher than this calculation 

indicates.

2. The NOSB has previously found (in 2006 and 2012, for anaerobic digestion of livestock 

and poultry manure) that the addition of sulfuric acid, even when followed by a step that 

neutralizes the acid, leaves behind a significant synthetic residue that has a functional 

effect in the agricultural system.

3. OMRI regards sulfuric acid and sulfate as prohibited, with limited specific exceptions.

4. The listing of liquid fish products is an instructive precedent indicating that when pH is 

adjusted with a synthetic, the product should be classified as synthetic.

Subcommittee Action & Vote

Classification Motion: 

Motion to classify Laminarin as nonsynthetic 

Motion by: Zea Sonnabend 

Seconded by: Harold Austin

Yes: 5 No: 2 Absent: 0 Abstain: 0 Recuse: 0 

Because laminarin was classified as non-synthetic, no further action by the Crops 

Subcommittee is necessary.

Approved by Zea Sonnabend, Subcommittee Chair, to transmit to NOSB February 26, 

2014

1 Compare this concentration to the Secondary Maximum Contaminant Level of sulfate in 

drinking water and the EU standard for drinking water --both 250 ppm.

31/186
32/186
Sunset 2015 Review List - Request for Public Comment

Crops Substances

*Reviewed and revised: February 26, 2014. 

Introduction

As part of the Sunset Process, the National Organic Program (NOP) announces substances on the 

National List of Allowed and Prohibited Substances (National List) that are coming up for sunset review 

by the National Organic Standard Board (NOSB). The following list announces substances that are on the 

National List for use in organic crop production that must be reviewed by the NOSB and renewed by the 

NOP before their sunset dates in 2015. This list provides the substance’s current status, use description, 

references to past technical reports, past NOSB actions, and regulatory history, as applicable. If a new 

technical report has been requested for a substance, this is noted in this list. To see if any new technical 

report is available, please check for updates under the substance name in the Petitioned Substances 

Database. 

Request for Comments

While the NOSB will not complete its review and any recommendations on these substances until the 

fall 2014 public meeting, the NOP is requesting that the public provide comments about these 

substances as part of the spring 2014 NOSB public meeting. These comments should be provided 

through www.regulations.gov by April 8, 2014 as explained in the meeting notice published in the 

Federal Register on March 10, 2014 

The Crops Subcommittee has posed specific questions to solicit public comments regarding the

substances due for sunset review by 2015. These questions are included in the listing for each substance 

below. 

It is important for the public to engage in the Sunset Process early. We strongly encourage submission of 

comments on these substances in advance of or at the spring 2014 meeting. Providing your comments 

early is important to: 1) ensure that the NOSB has adequate time and information to develop any 

proposals to remove substances based on this information before its Fall 2014 meeting; and, as such 2) 

provide stakeholders adequate opportunity to comment on any proposals to remove substances before 

NOSB votes and makes a recommendation at its fall 2014 meeting. 

These comments are necessary to guide the NOSB’s review of each substance against the criteria in the 

Organic Foods Production Act (7 U.S.C. 6518(m)) and the USDA organic regulations (7 CFR 205.600). The 

substances currently on the National List were originally recommended by the NOSB based on evidence 

available at the time of their last review that demonstrated that the substances were found to be: (1) 

not harmful to human health or the environment, (2) necessary because of the unavailability of wholly 

nonsynthetic alternatives, and (3) consistent and compatible with organic practices. 

Public comments should focus on providing new information about a substance since its last NOSB 

review. Such information could include research or data that may support a change in the NOSB’s 

determination for a substance. 

Guidance on Submitting Your Comments

Comments should clearly indicate your position on continuing the allowance of substances on this list 

and explain the reasons for your position. You should include relevant information and data to support 

your position (e.g., scientific, environmental, manufacturing, industry impact information, etc.). 

33/186
For Comments That Support Substances Under Review:

If you provide comments in support of an allowance of a substance on the National List, you should 

provide new information demonstrating that the substance is: 

(1) not harmful to human health or the environment;

(2) necessary to the production of the agricultural products because of the unavailability of wholly 

nonsynthetic substitute products; and 

(3) consistent with organic production. 

For Comments That Do Not Support Substances Under Review: 

If you provide comments that do not support a substance on the National List, you should provide 

reasons why the use of the substance should no longer be allowed in organic production or handling. 

Specifically, comments that support the removal of a substance from the National List should provide 

new information since its last NOSB review to demonstrate that the substance is: 

(1) harmful to human health or the environment; 

(2) unnecessary because of the availability of alternatives; and 

(3) inconsistent with organic production. 

For Comments Addressing the Availability of Alternatives: 

Comments may present information about the viability of alternatives for a substance under sunset 

review. Viable alternatives include, but are not limited to:

o Alternative management practices that would eliminate the need for the specific 

substance; 

o Other currently exempted substances that are on the National List, which could 

eliminate the need for this specific substance; and

o Other organic or nonorganic agricultural substances. 

Your comments should address whether any alternatives have a function and effect equivalent to or 

better than the allowed substance, and whether you want the substance to be allowed or removed from 

the National List. Assertions about alternative substances, except for those alternatives that already 

appear on the National List, should, if possible, include the name and address of the manufacturer of the 

alternative. Further, your comments should include a copy or the specific source of any supportive 

literature, which could include product or practice descriptions; performance and test data; reference 

standards; names and addresses of producers or handlers who have used the alternative under similar 

conditions and the date of use; and an itemized comparison of the function and effect of the proposed 

alternative(s) with substance under review. The following table can help you describe recommended 

alternatives in place of a current substance that you do not want to be continued.

Table 1. Guidance on submitting comments for alternatives to substances on the National List.

If the currently listed 

substance is used in... And is a... Then the recommended alternative should be a (an)... 

Crop Production Synthetic substance

- Another currently listed synthetic substance;

- Nonsynthetic substance; or

- Management practice. 

 

Written public comments will be accepted through April 8, 2014 via www.regulations.gov. Comments 

received after that date may not be reviewed by the NOSB before the meeting. 

34/186
SUNSET 2015: CROPS SUBSTANCES

Aqueous potassium silicate 

(Listing 1 of 2 – 205.601(e))

Synthetic

Use – As an insecticide (including acaricides or mite control).

Listing: Aqueous potassium silicate (CAS # 1312-76-1)—The silica, used in the manufacture of potassium 

silicate, must be sourced from naturally occurring sand.

Technical Reports: 2003 (PDF); 2014 (PDF)

Petition(s): Potassium Silicate (PDF) (2004), Potassium Silicate Supplemental (PDF) (2006)

Past NOSB Actions: NOSB review and recommendation for addition to the National List - 11/30/07. 

Regulatory Background: Proposed rule (including justification) published 6/3/2009 (74 FR 26591). 

Added to National List 12/13/2010 (75 FR 77521). 

Sunset Date: 12/14/2015

Specific Questions from Subcommittee

1. Potassium silicate makes plants more resistant to disease and herbivory, at least in part by 

concentrating silica. Humans and livestock are herbivores who might be consuming the treated plants. 

The 2014 Technical Report (TR) discusses how the foliar application of silicate can affect availability of 

micronutrients (TR 471-473), make plant tissues less tender and less digestible to humans and livestock 

(477-481 & 497-502), and lead to other morphological changes (487-490). Does the foliar application of 

potassium silicate in the quantity and frequency needed for insect and disease control have impacts on 

the nutritive value of treated foods that would exceed the impacts of silica obtained by the plant from 

natural soils? Are users employing mitigation strategies in consideration of these impacts? How should 

the NOSB weigh this impact on the nutritive value of treated plants?

2. Can organic management systems conserve and build available silicon in the soil in a ways that can be 

alternatives to potassium silicate? The 2014 TR suggests the following alternative practices: soilscaping, 

choice of variety and planting time, balancing silica accumulators and non-accumulators, moisture 

management, choice of mulch and ground cover, and scouting (661-689). Other forms of silica are also 

suggested as alternative materials (592-605). The subcommittee is interested in comments concerning 

nonsynthetic materials and practices being used in the field that would build comparable resistance to 

insects and fungi, while precluding the need for synthetic potassium silicate.

Reference: 7 CFR 205.601(e)

Aqueous potassium silicate 

(Listing 2 of 2 – 205.601(i))

Synthetic

Use – As plant disease control.

Listing: Aqueous potassium silicate (CAS # 1312-76-1)—The silica, used in the manufacture of potassium 

silicate, must be sourced from naturally occurring sand.

Technical Reports: 2003 (PDF); 2014 (PDF)

Petition(s): Potassium Silicate (PDF) (2004), Potassium Silicate Supplemental (PDF) (2006)

Past NOSB Actions: Recommended for addition to the National List on 11/30/07. 

Regulatory Background: Proposed rule (including justification) published 6/3/2009 (74 FR 26591). 

35/186
Added to National List 12/13/2010 (75 FR 77521). 

Sunset Date: 12/14/2015

Reference: 7 CFR 205.601(i)

Sodium carbonate 

peroxyhydrate

Synthetic

Use – As an algaecide.

Listing: Sodium carbonate peroxyhydrate (CAS # 15630-89-4)—Federal law restricts the use of this 

substance in food crop production to approved food uses identified on the product label.

Technical Reports: 2006 (PDF); 2014 (PDF)

Original Petition: Sodium Carbonate Peroxyhydrate (PDF) (2005)

Past NOSB Actions: Recommended for addition to the National List on 11/30/07. 

Regulatory Background: Proposed rule (including justification) published 6/3/2009 (74 FR 26591). 

Added to National List 12/13/2010 (75 FR 77521). 

Sunset Date: 12/14/2015

Specific Questions from Subcommittee

1. The subcommittee is seeking input on the comparison of this material to copper sulfate for control of 

algal scum in rice production and whether it can replace copper sulfate for that use.

Reference: 7 CFR 205.601(a)

Sulfurous acid Synthetic

Use – As plant or soil amendment.

Listing: Sulfurous acid (CAS # 7782-99-2)—for on-farm generation of substance utilizing 99% purity 

elemental sulfur per paragraph (j)(2) of this section.

Technical Reports: 2010 (PDF); 2014 (PDF)

Original Petition: Sulfurous Acid (PDF) (2008)

Past NOSB Actions: Recommended for addition to the National List on 5/09

Regulatory Background: Proposed rule (including justification) published 1/12/2010 (75 FR 1555). 

Added to National List 7/6/2010 (75 FR 38693). 

Sunset Date: 7/7/2015

Specific Questions from Subcommittee

1. The Crops Subcommittee is interested in the conditions under which sulfurous acid undergoes the 

transformation to sulfate, and conditions under which that sulfate is available as a plant nutrient. The 

2014 TR describes the chemistry of sulfurous acid in the soil at lines 64-67, 140-149, and 261-264. The 

subcommittee seeks comments that address the following questions: Are there specific soil and 

ecological (e.g., moisture) conditions under which the transformation to sulfate would be made and the 

sulfate made available? On the other hand, are there soil and ecological conditions that would result in 

the build-up of hydrogen sulfite, sulfate, or other products of sulfurous acid? Are there management 

practices that can be used by the grower to affect whether the transformation occurs and the sulfate is 

available to crops? Are there evaluation tools that can be used by farmers and certifiers to determine 

36/186
which of the above soil conditions are present?

2. The subcommittee would like public input on whether sulfurous acid is used to remedy conditions 

resulting from unsustainable agricultural practices. If so, how can this be evaluated by the NOSB in the 

sunset review of this material?

Reference: 7 CFR 205.601(j)

37/186
38/186
National Organic Standards Board

Livestock Subcommittee

Synthetic Methionine (MET) in Organic Poultry Feed Proposal

August 20, 2013

Reviewed February 3, 2014 - No revisions 

Summary of Proposed Action

The Livestock Subcommittee proposes to revise the current allowance of synthetic methionine

(MET) to read: 

DL–Methionine, DL–Methionine—hydroxy analog, and DL–Methionine—hydroxy analog 

calcium (CAS #'s 59-51-8, 583-91-5, 4857-44-7, and 922-50-9)——for use only in organic 

poultry production at the following maximum average pounds per? ton of 100% synthetic 

methionine in the diet over the life of the flock: Laying and broiler chickens – 2 pounds; 

Turkeys and all other poultry – 3 pounds.

The Livestock Subcommittee would also like to propose NOP Guidance for Certifying Agents 

and Industry on how to calculate and verify the use and allowance of synthetic MET expressed 

as a maximum average pounds per ton of 100% synthetic methionine in the diet over the life of 

the bird.

Introduction

The current organic standards allow for the use of synthetic MET for use only in organic poultry 

production at the following maximum levels of synthetic MET per ton of feed: Laying and broiler 

chickens—2 pounds; turkeys and all other poultry—3 pounds.

The allowed rates represent “step down” levels that were recommended by NOSB in April 2010, 

codified in a final rule on September 19, 2012, and went into effect on October 2, 2012. 

NOSB recommended the step down rates in order to balance various interests including: (i) 

Providing for the basic maintenance requirements of organic poultry; (ii) satisfying consumer 

preference to reduce the use of synthetic MET in organic poultry production; and (iii) motivating 

the organic poultry industry to continue the pursuit of commercially sufficient sources of 

allowable natural sources of MET. 

However, in the attempt to balance interests, the 2010 NOSB recommendation included an 

allowance for synthetic methionine expressed as a total maximum limit of pounds of MET per 

ton of feed, while the Methionine Task Force (MTF) July 2009 petition requested that 

methionine rates be expressed as an average over the life of the flock. The rates expressed as 

a maximum limit do not address MET demands when laying chicks first come into production.

In the NOP Proposed Rule published in the Federal Register on February 6, 2012, the NOP 

recognized that on April 8, 2011, the MTF submitted a new petition for revised maximum 

allowable levels of synthetic MET expressed as an average per ton of feed over the life of the 

bird as originally requested in the 2009 petition. As stated in the preamble to the Proposed Rule:

“The NOP anticipates that the NOSB will consider this petition at a future meeting. In the 

meantime, the NOP believes it is necessary to move forward issuing this proposed rule to 

39/186
address the April 2010 NOSB recommendation. This is necessary to prevent any gap in the 

allowance of synthetic methionine in the diets of organic poultry due to the current expiration 

date of October 1, 2012.” – (Federal Register/Vol. 77, No. 24/Monday, February 6, 2012 pg. 

5719).

This NOSB proposal addresses the petition submitted by the MTF on April 8, 2011.

Background

MET is classified as an essential amino acid because it cannot be biologically produced by 

poultry and is necessary to maintain viability. MET is required for proper cell development and 

feathering in poultry. Natural feed sources with a high percentage of MET include blood meal, 

fish meal, crab meal, corn gluten meal, alfalfa meal, and sunflower seed meal. Synthetic MET is 

also used in poultry feed. This substance is a colorless or white crystalline powder that is 

soluble in water. It is regulated as an animal feed nutritional supplement by the Food and Drug 

Administration (21 CFR 582.5475).

The NOSB initiated a review of this substance in 1999, as a result of a petition requesting to add 

synthetic Met to the National List for poultry. In 2001, the NOSB evaluated a technical advisory 

panel analysis of MET against the criteria provided in the OFPA (7 U.S.C. 6517–6518), and 

determined that the use of synthetic MET feed supplementation is compatible with a system of 

organic poultry production. Consistent with the NOSB’s recommendation, the Secretary 

amended § 205.603 of the National List on October 31, 2003, to allow MET as a synthetic 

substance for use in organic poultry production until October 21, 2005 (68 FR 61987).

Based upon subsequent NOSB recommendations in March 2005 and May 2008, the Secretary 

amended the listing for MET to continue the use through October 21, 2008 (70 FR 61217), and 

again through October 1, 2010 (73 FR 54057). The 2005 and 2008 NOSB recommendations to 

continue the allowance for MET were informed by updates on the development of allowable 

natural alternatives, none of which had attained commercial viability. While expressing a strong 

preference for supplementation with allowable natural sources of MET, the NOSB concluded 

that terminating the allowance for synthetic MET would disrupt the well-established organic 

poultry market, and cause substantial economic harm to organic poultry producers. The NOSB 

and stakeholders agreed that the organic feed sector would continue to research and develop 

sufficient supplies of allowable organic and natural sources.

On July 31, 2009, the MTF, which is comprised of organic poultry producers, submitted a new 

petition requesting to extend the allowance for synthetic MET for five years until October 2014. 

In addition, the MTF proposed that the total amount of synthetic MET in the diet remain below 

the following levels, calculated as the average pounds per ton of 100% synthetic MET over the 

life of the bird: 

Laying chickens—4 pounds; broiler chickens— 5 pounds; and, turkey and all other 

poultry—6 pounds. 

In consideration of the July 2009 petition and public comments, the NOSB issued two 

recommendations on April 29, 2010. These recommendations acknowledged a need for the 

continued allowance of synthetic MET, and conveyed the intent to decrease the amount of 

synthetic MET allowed in organic poultry production and encourage development of natural 

alternatives. One recommendation proposed to allow synthetic MET in organic poultry 

production until October 1, 2012, at the following maximum levels per ton of feed: 

40/186
Laying chickens—4 pounds; broiler chickens—5 pounds; and turkey and all other 

poultry—6 pounds. 

The NOP codified this recommendation through a National List amendment published in the 

Federal Register on August 24, 2010 (75 FR 51919), and reaffirmed on March 14, 2011 (76 FR 

13501).

The second NOSB recommendation from April 2010 proposed reduced maximum levels of 

synthetic MET after October 1, 2015. The NOSB recommended that the annotation or synthetic 

MET be revised to read: 

For use only in organic poultry after October 1, 2012, at the following maximum levels per 

ton: laying and broiler chickens—2 pounds per ton; turkeys and all other poultry—3 

pounds per ton. 

The NOP issued a proposed rule in the Federal Register to amend the National List to reflect 

the 2010 recommendation on February 6, 2012 followed by a final rule published in the Federal 

Register on September 19, 2012:

DL-Methionine, DL-Methionine-hydroxy analog, and DL-Methionine-hydroxy analog 

calcium (CAS #'s 59-51-8, 583-91-5, 4857-44-7, and 922-50-9)—for use only in organic 

poultry production at the following maximum levels of synthetic methionine per ton of feed: 

Laying and broiler chickens—2 pounds; turkeys and all other poultry—3 pounds

The amended listing removed the expiration date of 2012 and subjected synthetic MET at rates 

listed above to review within five years in accordance with the OFPA provision for the sunset of 

National List substances (7 U.S.C 6517(e)). Synthetic MET is now subject to a sunset review by 

the NOSB by 2017.

Relevant areas in the Rule

7 CFR §205.603(d)(1) - Synthetic substances allowed for use in organic livestock production. 

As feed additives. 

Discussion

Much is known about the nutritional needs of poultry and the feedstuffs available to poultry 

producers. The dietary demand for total MET declines with age for broilers and turkeys, while 

there is a decline during the early stages of pullet development, it increases just before laying 

begins and trails off as the birds age. The current proposal is somewhat of an estimate of the 

average demand for each class of birds based on the demand charts. Producers are feeding 

additional levels of protein, commonly soybean meal, to their birds in an attempt to meet the 

MET needs of the birds. This in effect is over feeding numerous amino acids in order to get 

enough MET into the birds. During the winter months, the birds would consume enough feed to 

meet their needs, but the additional protein in the feed was excreted into the barns causing 

ammonia levels to rise and blisters on the bird’s feet. During the summer months, the birds 

naturally consume less feed as their nutritional maintenance requirement is lower, they cannot 

consume enough feed to meet the necessary level of MET. Producers and certifiers are seeing 

an increase in feather pecking which can lead to cannibalism, agitation and nervousness and 

41/186
other behavioral issues. This behavior change is an animal welfare issue and the organic 

producers fail to understand why a logical solution cannot be adopted. If the rations could be 

tailored to the needs of the animal, why would the organic regulations prevent them from doing 

the right thing for the bird, especially if the overall intake would be at or below the allowed 

maximum over the course of its life.

Previous NOSB deliberations have discussed alternative sources for synthetic MET. The MTF 

has invested lots of time and money seeking viable alternatives for their industry in an effort to 

meet consumer expectations. High MET corn has production and yield issues. Corn variety 

trials are ongoing with the hopes this breeding work will be able to develop varieties that supply 

the appropriate amount of necessary amino acids. Pasture may provide some supplementation 

during the right conditions, but is certainly not a dependable solution. Other feed grains may 

have higher MET levels than corn, but have lower overall protein or may be limiting in other 

amino acids which makes them improbable solutions. The EU uses corn gluten meal to balance 

the MET demand since synthetic MET is not allowed, but 5% of their rations do not have to be 

organic. Organic corn gluten meal is not available to US producers. Fish meal and crab meal 

are used by some organic producers, while others are concerned about off flavors, and the 

availability is very low as most of these products are stabilized for transport with non-compliant 

stabilizers. Many organic consumers are looking for vegetarian based production systems as 

well. The NOSB Livestock Subcommittee put forth a discussion document on feeding animal 

byproducts to poultry as an alternative source of MET and while there was a minority that 

agreed with the proposal, the majority deemed that organic principles would be compromised. 

Because there is so much interest to find an alternative to synthetic MET for organic producers, 

numerous projects around the world are evaluating herbal and insect based sources. Because 

of the need for U.S. Food and Drug Administration (FDA) approval, these will be many years out 

if determined to be suitable alternatives. 

Under this proposal, producers will have an increased liability to document feeding rates to 

document compliance with the regulation. Certifiers will have to develop tracking systems with 

producers and their feed mills to verify compliance. Larger poultry operations change the 

rations frequently to keep cost down by only feeding to meet the bird’s needs. These operations 

will have detailed records on flock age, size, and feed rations fed on a daily basis. It will be 

somewhat complicated if a pullet flock is transferred to another farmer for egg production, who 

is with another certifier. All the feed documentation will have to follow as well. Smaller 

operations often feed the same ration throughout the life cycle of the bird and therefore would 

never feed more than the average. Certifiers have indicated that mechanisms can be developed 

with their clients, suitable to verify compliance with the regulation. They are in part motivated by 

the behavioral issues being reported by their inspectors during this first season under the new 

cap. The NOP may need to issue Guidance Documents or Instructions to certifiers to clarify how 

verification can be obtained. Certifiers affiliated with the Accredited Certifiers Association (ACA) 

often work together and help each other gain consistency in areas like this. This could also be a 

part of the annual training for certifiers conducted by the NOP and ACA.

The NOSB Livestock Subcommittee is unsure of how certifiers will handle a situation if the flock 

goes out of production prior to the average being below the regulatory cap. We are uncertain as 

to whether this would be a noncompliance that must not be repeated or a willful violation 

indicating civil penalties.

Calculating MET allowances average over the life of the flock, will result in the following:

• Feed rations can better adjust to the naturally changing demands of the bird. Poultry 

farmers will have more flexibility to appropriate adjust diets for stage of life, seasonality, 

42/186
breed, etc.;

• Overall usage of MET will be lowered. Producers can only add MET to the average cap,

not consistently add MET at the maximum rate;

• Farmers and nutritionists will still be only marginally capable of meeting the bird’s basic 

needs. The organic poultry industry will continue to have a tremendous incentive to 

actively evaluate novel sources of MET. With continued research and the development 

of effective alternatives proven to meet the demands of the organic poultry sector, the 

NOSB Livestock Subcommittee believes that MET can eventually be eliminated from 

organic production. 

Current listing on the National List:

DL-Methionine, DL-Methionine-hydroxy analog, and DL-Methionine-hydroxy analog 

calcium (CAS #'s 59-51-8, 583-91-5, 4857-44-7, and 922-50-9)—for use only in organic 

poultry production at the following maximum levels of synthetic methionine per ton of feed: 

Laying and broiler chickens—2 pounds; turkeys and all other poultry—3 pounds.

The regulations currently express a total maximum limit of pounds of MET per ton of feed. 

Consistent with the petition from July 2009 and April 2011, this proposal requests that MET

rates be expressed as an average per ton of feed over the life of the flock. 

Recommended Committee Action & Vote

Motion to accept the following amendment at §205.603(d): DL–Methionine, DL–Methionine—

hydroxy analog, and DL–Methionine—hydroxy analog calcium (CAS #'s 59-51-8, 583-91-5, 

4857-44-7, and 922-50-9) -for use only in organic poultry production at the following maximum 

average pounds per ton of 100% synthetic methionine in the diet over the life of the flock: 

Laying and broiler chickens – 2 pounds; Turkeys and all other poultry – 3 pounds.

Motion by: Mac Stone 

Seconded by: Francis Thicke

Yes: 7 No: 0 Abstain: 0 Absent: 2 Recuse: 0 

Further Clarification of the Proposed Amendment

Under this recommendation, producers would be able to exceed the above levels on a particular 

formulation, provided that there was an offsetting formulation below the level, such that the 

average inclusion rate of 100% synthetic MET over the entire life cycle of the flock was below 

the allowed maximum level.

Reference is specifically made to 100% synthetic MET, as some forms of synthetic MET (e.g. 

the liquid form Alimet) are not 100% MET. The maximum pounds as shown above is based on 

the 100% synthetic MET equivalent so that a consistent standard can be applied to all organic 

operations, irrespective of the form of MET they are using (e.g. wet vs. dry).

Approved by Tracy Favre, Subcommittee Chair, to transmit to NOSB August 20, 2013

43/186
44/186
National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Acidified Sodium Chlorite (ASC) 

August 20, 2013

Reviewed January 7, 2014 - No revisions

Summary of Proposed Action:

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment x Yes ☐No ☐ N/A 

2. Essential & Availability Criteria ☐ Yes x No ☐ N/A

 3. Compatibility & Consistency x Yes ☐ No ☐ N/A

Substance Fails Criteria Category: 2 

Comments: 

Acidified Sodium Chlorite (ASC) was petitioned for use as a pre and post teat dip treatment in organic livestock 

production. ASC is currently allowed on the national list as a disinfectant for direct food contact under 

205.605(b). After carefully reviewing the petition, along with the Technical Evaluation Report prepared for the 

committee in 2013, we have found that this material generally satisfies the criteria related to impact on humans 

and the environment, along with general compatibility and consistency with organic principles. However, the 

TR notes that a number of functional alternative substances are available, and the committee’s research and 

outreach to producers confirms that many substances are already used as mastitis-preventing teat dips. 

Accordingly, the essentiality criteria are not met, and the committee does not recommend the addition of ASC 

to the national list as a teat dip. 

Subcommittee Action & Vote

Classification Motion: Motion to classify Acidified Sodium Chlorite (CAS # 7758-19-2 (sodium chlorite) 

and CAS # 14998-27-7 (chlorous acid)) as synthetic. 

Motion by: Joe Dickson

Seconded by: Colehour Bondera

Yes: 8 No: 0 Absent: 1 Abstain: 0 Recuse: 0 

Listing Motion: Motion to list Acidified Sodium Chlorite(CAS #s 13898-47-0 (Chlorous Acid), 7758-19-2 

(Sodium Chlorite)) at §205.603(a) and 205.603(b) of the National List annotated as follows: Acidified 

Sodium Chlorite, Allowed for use on organic livestock as a pre and post teat dip treatment, acidified with 

lactic acid or other GRAS acid. 

Motion by: Joe Dickson

Seconded by: Colehour Bondera

Yes: 0 No: 8 Abstain: 0 Absent: 1 Recuse: 0

 Basis for annotation: x To meet criteria above ☐ Other regulatory criteria ☐ Citation 

 Approved by Tracy Favre, Subcommittee Chair, to transmit to NOSB August 20, 2013 

45/186
NOSB Evaluation Criteria for Substances Added To the National List :Livestock

Category 1. Adverse impacts on humans or the environment? Acidified Sodium Chlorite

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse,? 

[§6518(m)(3)]

x Risk is minimal. TR page 9, lines 359-

369. 

2. Is there a probability of environmental 

contamination during manufacture or 

disposal? [§6518(m)(3)]

x TR page 9, lines 359-390.

3. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

x

4. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)]

x As petitioned, substance does not 

interact with the agroecosystem. TR page 

10 lines 410-411.

5. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518(m)(2)]

x Breakdown products are citric acid, salt 

and water (2009 handling 

recommendation). 

6. Is there persistence or concentration of 

the material or breakdown products in 

the environment? [§6518(m)(2)]

x When used as petitioned, SCA and its 

components exhibit minimal likelihood of 

persistence in the environment. TR page 

7 lines 296-298. 

7. Would the use of the substance be 

harmful to human health or the 

environment? [§6517 (c)(1)(A)(i); §6517 

(c)(2)(A)(i); §6518(m)(4)]

x “When used as petitioned, acidified 

sodium chlorite and its component 

chemicals exhibit minimal likelihood of 

persistence or accumulation in the 

environment.” TR page 10, lines 436-428. 

The material is both GRAS and on the 

USDA National List for handling. 

8. Are there adverse biological and 

chemical interactions in the agroecosystem, including biodiversity? 

[§6518(m)(5)]

x As petitioned, substance does not 

interact with the agroecosystem. TR page 

10 lines 410-411.

9. Are there detrimental physiological 

effects on soil organisms, crop- s, or 

livestock? [§6518(m)(5)]

x As petitioned, substance does not 

interact with the agroecosystem. TR page 

10 lines 410-411.

46/186
NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 2. Is the Substance Essential for Organic Production: Acidified Sodium Chlorite

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] x TR page 7, lines 280-293.

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

x TR page 6, lines 222-279

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

x The substance is synthetically produced. 

TR page 7, lines 280-293.

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

x The substance is synthetically produced. 

TR page 7, lines 280-293.

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

x TR page 7. 

6. Is there an organic substitute? 

[§205.600(b)(1)]

x There are a limited number of organic or 

natural substances that are appropriate 

substitutes. Nisin, a natural material that 

may be a substitute, is not authorized for 

use as a teat dip due to earlier rejection 

by NOSB as an antibiotic . A number of 

essential oils and organic acids may also 

be used as teat dips. TR page 11, lines 

542-547

7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)]

x x See above. 

8. Are there any alternative substances? 

[§6518(m)(6)]

x The TR also suggests that a number of 

alternative substances, including iodine, 

alcohols, chlorine materials, hydrogen 

peroxide, chlorhexadine and certain 

essential oils may function as 

alternatives.

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)]

x Teat dips are critical in commercial dairy 

production to prevent mastitis. TR page 

12.

47/186
NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 3. Is the substance compatible with organic production practices? Acidified Sodium Chlorite

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

x TR, petition. Substance is already 

allowed for use in handling in direct food 

contact.

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

x

3. If used in livestock feed or pet food, Is 

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

x

4. If used in livestock feed or pet food, Is

the primary use as a preservative? 

[§205.600(b)(4)]

x

5. If used in livestock feed or pet food, Is 

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)]

x

6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories: 

[§6517(c)(1)(B)(i); 

copper and sulfur compounds

x TR page 6, lines 210-221

toxins derived from bacteria x TR page 6, lines 210-221

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

x TR page 6, lines 210-221

livestock parasiticides and medicines x TR page 6, lines 210-221

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

x TR page 6, lines 210-221

48/186
National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Chlorine Materials in aquatic livestock production

August 20, 2013

*Reviewed and revised January 21, 2014

Summary of Proposed Action:

Chlorine Materials are petitioned for use in aquatic livestock production, to be added to 205.611 

- Synthetic substances allowed for use in organic aquatic animal production as follows:

(x) Chlorine materials—residual chlorine levels in the water shall not exceed the 

maximum residual disinfectant limit under the Safe Drinking Water Act.

(i) Calcium hypochlorite.

(ii) Chlorine dioxide

(iii) Sodium hypochlorite

Synthetic Chlorine is proposed to be added to the National list at 205.611 for use in aquatic 

animal production. Section 205.611 of the National List will contain the list of synthetic 

substances allowed in organic aquatic animal production.

Chlorine materials are widely used for their disinfectant properties, and are currently approved 

for such uses in crop, livestock and processed organic product production. The annotations on 

the National List for livestock and handling limit the use of chlorine materials to disinfection and 

sanitation, and require that residual chlorine levels be consistent with Safe Drinking Water Act 

levels. The NOP has also clarified the use of chlorine in production and handling in a guidance 

document, NOP 5026.

The Livestock Subcommittee has received a petition for the use of Chlorine Materials in aquatic 

livestock production. These materials are used in aquatic animal production for the disinfecting 

hard surfaces and culture water in nurseries, grow-out operations with tanks, harvest and 

slaughter equipment, and in processing facilities. Given that the materials’ use in aquaculture 

applications is identical to existing uses in other production categories, the committee has not 

requested a new Technical Evaluation Report, but it is instead relying on recent TR’s developed 

for Handling and Crops uses of this group of materials.

Evaluation Criteria Criteria Satisfied? 

1. Impact on Humans and Environment X Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria X Yes ☐ No ☐ N/A

3. Compatibility & Consistency X Yes ☐ No ☐ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes ☐ No X N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: N/A 

Recommended Committee Action & Vote

Classification Motion: Chlorine Materials (Calcium hypochlorite – CAS 7778-54-3; chlorine 

dioxide – CAS 10049-04-4; and sodium hypochlorite – CAS 7681-52-9) are synthetic.

49/186
Motion by: Jean Richardson 

Seconded by: Mac Stone 

Yes: 5 No: 1 Absent: 0 Abstain: 1 Recuse: 0

Listing Motion: Motion to list Chlorine Materials (Calcium hypochlorite- CAS 7778-54-3; 

chlorine dioxide- CAS 10049-04; and sodium hypochlorite – CAS 7681-52-9) at § 205.611 

with the following annotation : Chlorine materials - Disinfecting and sanitizing facilities and 

equipment. Residual levels in the water shall not exceed the maximum residual disinfecting 

limit under the Safe Drinking Water Act.

Motion by: Jean Richardson 

Seconded by: Mac Stone

Yes: 5 No: 1 Absent: 0 Abstain: 1 Recuse: 0

Basis for annotation: X To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: This annotation is consistent with other listings of Chlorine on the NL, and ensures 

that any environmental impact is effectively mitigated. 

 

Approved by Tracy Favre, Subcommittee Chair, to transmit to NOSB January 21, 2014

NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 1. Adverse impacts on humans or the environment? Chlorine Materials

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

X 2006 Crops TR lines 212-266. The TR 

identities several areas of potential 

environmental impact, but notes that 

existing EPA regulations and the 

annotation restricting effluent to the levels 

of the Safe Drinking Water Act are 

sufficient to mitigate any environmental 

impact. The petitioner and a number of 

producers have confirmed that chlorine 

materials are not used in direct contact 

with the environment (e.g. ponds and net 

pens) and the restrictive annotation would 

prohibit such uses regardless. 

2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

X See Question 1

3. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

X No. [2006 Crops TR]

50/186
4. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)]

X The annotation restricts use to levels no 

greater than those determined by the 

Safe Drinking Water Act, so the potential 

for detrimental chemical interaction is 

similar to that posed by municipal tap 

water. 

5. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518(m)(2)]

X The annotation restricts use to levels no 

greater than those determined by the 

Safe Drinking Water Act, so the potential 

for detrimental chemical interaction is 

similar to that posed by municipal tap 

water. Any presence of the substance in 

the overall agroecosytem would be 

required by the annotation to meet the 

requirements of the Safe Drinking Water 

Act, ensuring presence below 4 ppm.

6. Is there persistence or concentration of 

the material or breakdown products in 

the environment? [§6518(m)(2)]

X No. The substance degrades rapidly to 

naturally occurring compounds in the 

presence of air and sunlight [2006 Crops 

TR 417-432] This TR also confirms (in 

lines 384 –402) that these materials are 

not persistent in the environment in 

general, and that in water and soil, 

sodium and calcium hypochlorite 

separate into sodium, calcium and 

hypochlorite ions. Chlorine dioxide is also 

reactive and breaks down quickly. While 

the TER does not directly address its fate 

in aquatic environments, again, the 

annotation would limit the extent to which 

any chlorine material could be discharged 

into sea water or any other part of the 

environment.

7. Would the use of the substance be 

harmful to human health or the 

environment? [§6517 (c)(1)(A)(i); §6517 

(c)(2)(A)(i); §6518(m)(4)]

X See Q # 1

8. Are there adverse biological and 

chemical interactions in the agroecosystem, including biodiversity? 

[§6518(m)(5)]

X Any presence of the substance in the 

overall agroecosytem would be required 

by the annotation to meet the 

requirements of the Safe Drinking Water 

Act, ensuring presence below 4 ppm. 

9. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518(m)(5)]

X The substance is not used in direct 

contact with soil or terrestrial livestock. It 

is only used in contact with hard surfaces 

and equipment, or culture water. [2006 

Crops TR 322-327, petition]

51/186
NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 2. Is the Substance Essential for Organic Production? Chlorine Materials

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X Yes. 2006 TR Lines 149-171

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

X This process does not involve the 

chemical transformation of a natural 

substance; the starting materials are 

synthetic. 2006 TR Lines 177-178

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X 2006 TR Lines 183-184

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X 2006 TR Lines 183-184

6. Is there an organic substitute? 

[§205.600(b)(1)]

X 2006 TR Lines 183-184

7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)]

X Petition page 7-8 (notes the limitations on 

alternative materials) and 2011 Crops 

TER page 12.

8. Are there any alternative substances? 

[§6518(m)(6)]

X

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)]

X

52/186
NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 3. Is the substance compatible with organic production practices? Chlorine Materials 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

X

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

X

3. If used in livestock feed or pet food, Is 

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X

4. If used in livestock feed or pet food, Is 

the primary use as a preservative? 

[§205.600(b)(4)]

X

5. If used in livestock feed or pet food, Is 

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)]

X

6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories:

[§6517(c)(1)(B)(i); 

copper and sulfur compounds

X

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X

livestock parasiticides and medicines X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X

53/186
54/186
National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Tocopherols in aquatic animal production

August 22, 2013

*Reviewed and revised January 21, 2014

Summary of Proposed Action:

Synthetic Tocopherols are proposed to be added to the National List at 205.611 for use in 

aquatic animal production as an anti-oxidant added to feed. Section 205.611 of the National List 

will contain the list of synthetic substances allowed in organic aquatic animal production. 

Tocopherols were petitioned in 2012 by the Aquaculture Working Group for use in aquaculture 

livestock production. Tocopherols are a group of lipophilic phenolic antioxidants that occur 

naturally in a variety of plant species. Rich sources of naturally-occurring tocopherols include 

cereal grains, oilseeds, nuts, and vegetables (Burdock, 1997). The term “tocopherols” refers to 

structurally similar compounds that occur in nature in four forms: alpha-, beta-, gamma-, and 

delta-tocopherol (CIR, 2002). Tocopherols that are derived from plant products are often 

referred to as “mixed tocopherols” because the mixture contains all four forms of tocopherol 

(CIR, 2002). (TR lines 37-41). Tocopherols are mixed with fish oil, fishmeal, and other feed 

ingredients to prevent oxidation of the polyunsaturated fatty acids present in the lipids and 

thereby protect the nutritional value of the feed. Polyunsaturated fatty acids are very 

susceptible to autoxidation when exposed to oxygen in the atmosphere (Tacon, 1992). During 

the process of lipid autoxidation, toxic degradation products are formed in the feed that may 

cause pathological changes in the fish (Hardy and Roley, 2000). Furthermore, oxidation 

destroys essential fatty acids in the feed, and consuming oxidized lipids may have deleterious 

effects on tissue levels of vitamins C and E. Finally, oxidation of the lipids in fish meal 

generates heat that is sometime sufficient to cause spontaneous combustion of feeds (Hardy 

and Roley, 2000). Tocopherols are considered essential for the health of aquatic animals

Tocopherols are not specifically named in the National List as synthetic feed additives allowed 

for use in organic livestock production. However, mixed tocopherols are a source of vitamin E. 

Vitamins (used for enrichment or fortification when FDA approved) are included on the National 

List as synthetic ingredients allowed as feed additives in organic livestock production (7 CFR 

205.603[d][3]). Tocopherols derived from vegetable oil are allowed for use as ingredients in or 

on processed products labeled as “organic” or “made with organic (specified ingredients or food 

group[s])” when rosemary extracts are not a suitable alternative (7 CFR 205.605[b])(TR lines 

26-32).

Tocopherols are also affirmed as GRAS by the FDA when used as chemical preservatives (21 

CFR 582.3890) and nutrients and/or dietary supplements (21 CFR 582.5890) in animal feeds in 

accordance with good manufacturing or feeding practice. No sources were identified that 

discuss any negative effects of tocopherols on biological or chemical interactions in the aquatic 

agro-ecosystem, including nontarget aquatic organisms, physical water conditions, endangered 

species, or biodiversity. TR lines 464-466. “Tocopherols are currently permitted by Canadian, 

European, and Japanese Organic Standards, IFOAM and CODEX, although they may not 

specifically be permitted as antioxidants in livestock feed production.

 

In reviewing whether use of synthetic tocopherols is compatible with or essential to organic 

agriculture the subcommittee took into consideration the Organic Foods Production Act (OFP) 

which limits use of synthetics. Tocopherols are in the vitamin group listed at section 

6517(c)(1)(B)(i). 

55/186
It should be noted that at the time of drafting this proposal there are no federal standards 

promulgated for aquatic plant or animal production, and this proposal is based on the NOSB 

Recommendations of standards voted in 2007, 2008, and 2009. Therefore the livestock 

subcommittee recommends reassessment of this material when regulations for open and closed 

systems are in place.

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment X Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria X Yes ☐ No ☐ N/A

3. Compatibility & Consistency X Yes ☐ No ☐ N/A

Substance Fails Criteria Category: [ ] Comments: 

Subcommittee Action & Vote

Classification Motion: Motion to classify tocopherols, as petitioned, as synthetic.

Motion by: Jean Richardson 

Seconded by: Mac Stone

Yes: 6 No: 1 Absent: 0 Abstain: 0 Recuse: 0 

Listing Motion: Motion to list tocopherols at §205.611 of the National List for use in aquatic 

livestock production as an antioxidant added to aquatic animal feed with the following 

annotation: Tocopherols derived from vegetable oils are allowed as ingredients in aquatic 

livestock production when rosemary extracts are not a suitable alternative. 

Motion by: Jean Richardson 

Seconded by: Mac Stone

Yes: 6 No: 1 Absent: 0 Abstain: 0 Recuse: 0 

 Proposed Annotation (if any): Tocopherols derived from vegetable oils are allowed as 

ingredients in aquatic livestock production when rosemary extracts are not a suitable 

alternative.

Basis for annotation: x☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Minority Opinion: see end of document

Approved by Tracy Favre, Subcommittee Chair, to transmit to NOSB January 21, 2014

56/186
NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 1. Adverse impacts on humans or the environment? Tocopherols (aquatic animals)

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is there a probability of environmental 

contamination during, use or misuse?

[§6518(m)(3)]

X If solvents used in the manufacturing are 

released into the environment through 

waste streams, environmental 

contamination could occur. However, no 

sources were identified that discussed 

environmental contamination resulting 

from the manufacturing of tocopherols. 

(TR lines 498-501)

2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

X X The extraction of tocopherols from 

vegetable oil byproducts may include one 

or more of the following chemical 

processes: esterification, saponification, 

solvent extraction, and/or crystallization 

using a solvent (TR 281-314). Physical 

separation methods may also be used 

during the extraction of tocopherols, and 

these include various distillation steps. 

Solvents used include: hexane, ethanol, 

isopropanol, acetone, isopentane, 

isohexane, and trichloroethylene (TR 

lines 282-284). Can also be made from a 

byproduct of vegetable oil refining (oils of 

soybean, canola, sunflower, corn, and 

cottonseed, some of which may be 

genetically engineered) (TR lines 289-

292). 

3. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

X

4. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems? [§6518(m)(1)]

X TR lines 451-450.

5. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518(m)(2)]

X Excessive intake of tocopherols above 

the vitamin E requirement of fish could 

result in hypervitaminosis E, a condition 

of high storage levels of the vitamin in the 

fish which could result in toxic symptoms 

such as poor growth, toxic liver reaction, 

and death (De Silva et al., 2012; Halver, 

2002) (TR lines 480-483). 

57/186
6. Is there persistence or concentration of 

the material or breakdown products in 

the environment? [§6518(m)(2)]

X Tocopherols exert their antioxidant 

properties by reacting with free radicals, 

so they are unlikely to persist. Oxidized 

tocopherols can be recycled in the 

presence of other antioxidants, however, 

and some of the metabolites of 

tocopherols can be toxic.1

7. Would the use of the substance be 

harmful to human health or the 

environment? [§6517 (c)(1)(A)(i); §6517 

(c)(2)(A)(i); §6518(m)(4)]

X See TR lines 393-439.

The tocopherol level found in the flesh of 

a fish is related to the fish’s total dietary 

intake of tocopherols (Sargent et al., 

2002). The use of tocopherols as an 

antioxidant or vitamin supplement in 

aquatic animal feed will possibly increase 

tocopherol levels in those fish that 

consume the feed, with unknown effects 

on the human consumer (TR lines 522-

524). 

No sources were identified that discuss 

adverse effects upon human health from 

the use of tocopherols as an antioxidant 

in aquatic or terrestrial animal feed. It is 

unlikely that the use of tocopherols as an 

antioxidant in aquatic animal feed would 

be harmful to human health. (TR lines 

509-511)

8. Are there adverse biological and 

chemical interactions in the agroecosystem, including biodiversity? 

[§6518(m)(5)]

X No sources were identified that discuss 

any negative effects of tocopherols on 

biological or chemical interactions in the 

aquatic agro-ecosystem, including 

nontarget aquatic organisms, physical 

water conditions, endangered species, or 

biodiversity. (TR lines 464-466.)

9. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518(m)(5)]

X

Category 2. Is the Substance Essential for Organic Production? Tocopherols (aquatic animals)

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X TR lines 276-369.

The 1995 Technical Advisory Panel 

(TAP) Report for Tocopherols, which 

1 Aalt Bast and Guido R.M.M. Haenen, 2002. The toxicity of antioxidants and their metabolites. Environmental 

Toxicology and Pharmacology 11 (2002) 251–258.

58/186
reviewed the use of tocopherols as a food 

antioxidant, states that tocopherols are 

made via vacuum steam distillation of 

edible vegetable oil products (NOSB, 

1995). (TR lines 285-287)

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

X (TR lines 276-369.) Synthetics are added 

in extraction process. 

All of the methods found in the literature 

involve chemical processes. At the end 

of the process used to extract and purify 

tocopherols, the compounds remain in 

the same form as in the naturally 

occurring source materials. (TR lines 

320-322)

The petitioner provided a material safety 

data sheet (MSDS) for a product called 

Naturox® IPO Liquid (Kemin Industries, 

Inc.) which lists organic sunflower oil, 

lecithin, and rosemary extract as 

components of the mixed tocopherols 

formulation (Kemin Industries, Inc., 

2008). The Joint Expert Committee on 

Food Additives (JECFA) specification for 

the food additive “mixed tocopherols 

concentrate” states that it may contain an 

edible vegetable oil added to adjust the 

required amount of total tocopherols 

(JECFA, 2006). Powdered forms of 

mixed tocopherols contain a carrier such 

as tapioca starch, gum acacia, and/or 

maltodextrin (Organic Technologies, 

2009; NOSB, 1995). No additional 

sources were found that discuss possible 

additives to commercially-produced 

tocopherols for use as antioxidants in 

food or feed, including aquaculture feed 

products. (TR lines 55-63)

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X X Naturally occurring tocopherols exist. But 

the petition is for synthetic tocopherols.

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X Tocopherols are a group of lipophilic 

phenolic antioxidants that occur naturally 

in a variety of plant species. Rich 

sources of naturally-occurring 

tocopherols include cereal grains, 

oilseeds, nuts, and vegetables (Burdock, 

1997). The term “tocopherols” refers to 

structurally similar compounds that occur 

in nature in four forms: alpha-, beta-, 

gamma-, and delta-tocopherol (CIR, 

2002). Tocopherols that are derived from 

59/186
plant products are often referred to as 

“mixed tocopherols” because the mixture 

contains all four forms of tocopherol (CIR, 

2002). (TR lines 37-41)

6. Is there an organic substitute? 

[§205.600(b)(1)]

X Organic Rosemary oil may work in some 

applications.

7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)] 

X Rosemary extract, lecithin, vitamin C, 

natural sources of vitamin E (eg, wheat 

germ oil), and others (TR lines 531-583).

8. Are there any alternative substances? 

[§6518(m)(6)]

X See 7 above.

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)]

X No sources were identified that 

discussed alternative practices that would 

make the use of an antioxidant 

unnecessary in aquatic animal feed (TR 

595-597).

Category 3. Is the substance compatible with organic production practices? Tocopherols 

(aquatic animals)

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

X Synthetic tocopherols are currently 

permitted for specific uses in organic 

livestock production and organic 

handling. Tocopherols are not 

specifically named in the National List as 

synthetic feed additives allowed for use in 

organic livestock production. However, 

mixed tocopherols are a source of vitamin 

E. Vitamins (used for enrichment or 

fortification when FDA approved) are 

included on the National List as synthetic 

ingredients allowed as feed additives in 

organic livestock production (7 CFR 

205.603[d][3]). Tocopherols derived from 

vegetable oil are allowed for use as 

ingredients in or on processed products 

labeled as “organic” or “made with 

organic (specified ingredients or food 

group[s])” when rosemary extracts are 

not a suitable alternative (7 CFR 

205.605[b])(TR lines 26-32). 

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

X See 1 above

3. If used in livestock feed or pet food, Is 

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X Tocopherols are mixed with fish oil, fish 

meal, and other feed ingredients to 

prevent oxidation of the polyunsaturated 

fatty acids present in the lipids and 

60/186
thereby protect the nutritional value of the 

feed. Polyunsaturated fatty acids are 

very susceptible to autoxidation when 

exposed to oxygen in the atmosphere 

(Tacon, 1992). During the process of 

lipid autoxidation, toxic degradation 

products are formed in the feed that may 

cause pathological changes in the fish 

(Hardy and Roley, 2000). (TR lines 99-

105) Furthermore, oxidation destroys 

essential fatty acids in the feed, and 

consuming oxidized lipids may have 

deleterious effects on tissue levels of 

vitamins C and E. 

4. If used in livestock feed or pet food, Is 

the primary use as a preservative? 

[§205.600(b)(4)]

X Oxidation of the lipids in fish meal 

generates heat that is sometime sufficient 

to cause spontaneous combustion of 

feeds (Hardy and Roley, 2000). (TR lines 

107-109) Tocopherols are used to 

stabilize fishmeal and are required under 

law if fishmeal is to be transported.

5. If used in livestock feed or pet food, Is 

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)]

X See comments at Item 3 above.

6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories: 

[§6517(c)(1)(B)(i); 

copper and sulfur compounds

X

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X Tocopherols are in the vitamin group

livestock parasiticides and medicines X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X

61/186
Minority Opinion - Tocopherols in aquatic animal production

February 21, 2014

Since this petition is being considered in the absence of regulations defining acceptable 

practices in organic aquaculture, essentiality in particular cannot be judged at this time, so the 

NOSB needs to reconsider the approval in five (5) years. The minority believes that there should 

be a five-year expiration date as an annotation. Current consideration of the material has raised 

issues relating to health or environmental impacts, especially relating to those relating to 

extractants, as well as alterative natural materials. The review in five (5) years provides an 

opportunity for the Board to monitor the use of the material, update its scientific and essentiality 

review, incentivize alternatives and continuous improvement, and vote on continued or modified 

use of the material under the same standard of review that is used to approve the material 

during its petition review, pending the receipt of a petition requesting the use be extended.

The minority also has concerns about the unnecessary presence of volatile synthetic solvents in 

tocopherols. The Livestock Subcommittee received a letter from Oh Oh Organics supporting the 

consistent availability of natural tocopherols extracted without synthetic solvents. The letter 

states, 

I have sold Non-GMO, non-solvent extracted tocopherol since 2005. Both BASF, an 

international ingredient manufacturer out of Germany and BTSA, a company specializing 

in non-GMO Tocopherols supply this material. It is consistently available and is broadly 

used in the food, cosmetic and household cleaning business. Additionally I have seen 

ISO certified documents for a supplier in China...so, I believe it available around the 

world.

The minority believes that the use of synthetic tocopherols is incompatible with organic 

agriculture because:

• It is inconsistent with use of vitamins in terrestrial animals, where they are restricted to 

use for, “enrichment or fortification when FDA approved.” 

• It is a synthetic preservative.

62/186
National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Minerals in aquatic animal production

August 6, 2013

*Reviewed and revised February 3, 2014

Summary of Proposed Action:

Synthetic minerals are proposed to be added to the National List at 205.611 for use in 

production of aquatic animals. Section 205.611 of the National List will contain the list of 

synthetic substances allowed in organic aquatic animal production.

Synthetic Trace Minerals are presently approved at 205.603(d)(2) for use in livestock 

production, used for “enrichment and fortification when FDA approved”.

Minerals are essential for production of healthy animals. In the case of nutrient requirements for 

fish and shrimp, the National Research Council (NRC) defines essential trace minerals as 

“required”. Petitioner requests addition to the National List of trace minerals without specific 

notation to include but not to be limited to the following: Cobalt Chloride, Copper, Potassium 

iodide, Ethanediamine dihydroiodide, Ferric Sulfate, Ferric citrate, Manganese sulfate, Sodium 

Selanate, Sodium Selanite Sodium Chloride, and Zinc Sulfate.

Minerals are produced using chemical synthesis and extraction from either natural or reclaimed 

sources and while a range of potential environmental impacts may occur from excess and 

improper disposal during manufacture, under normal animal feeding the risks to the 

environment are low, and human health effects specifically related to trace minerals in aquatic 

animal feeds have not been reported.

Minerals are included as ingredients in feed pellets at approximately 0.1% to o.2% of feed pellet 

mass. The dietary importance of a given trace mineral is conditional on the animal species 

being grown.

In considering alternative sources for trace minerals as petitioned it should be noted that feeding 

wild caught fish, fish meal, other animal based meals, together with plant based feeds such as 

soy, corn, cottonseed etc. could provide a balanced diet without the fortification of feed with 

synthetic trace minerals.

In reviewing whether minerals are compatible with organic agriculture the subcommittee took 

into consideration the Organic Food Production Act (OFPA) which limits the use of synthetics to 

various categories, one of which is “pheromones, soaps, horticultural oils, fish emulsions, 

treated seeds, vitamins and minerals”.

It should be noted that at the time of drafting this proposal there are no federal standards 

promulgated for aquatic plant or animal production and this proposal is based on NOSB 

Recommendations voted in 2007, 2008, and 2009

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment x☐ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria x☐ Yes ☐ No ☐ N/A

3. Compatibility & Consistency x☐ Yes ☐ No ☐ N/A 

63/186
Substance Fails Criteria Category: N/A

Subcommittee Action & Vote, including classification proposal (state actual motion):

Classification Motion: Motion to classify Minerals as synthetic: 

Motion by: Francis Thicke 

Seconded by: C. Reuben Walker

Yes: 7 No: 0 Absent: 0 Abstain: 0 Recuse: 0#

Listing Motion: Motion to list Minerals at §205.611 of the National List.

Motion by: Francis Thicke 

Seconded by: C. Reuben Walker

Yes: 6 No: 1 Absent: 0 Abstain: 0 Recuse: 0 

 Proposed Annotation (if any): None

Basis for annotation: ☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Minority Opinion: see end of document

Approved by Tracy Favre, Subcommittee Chair, to transmit to NOSB February 3, 2014

NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 1. Adverse impacts on humans or the environment? Minerals (aquatic animals) 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

X When used as petitioned trace minerals 

from unconsumed feed pellets have the 

potential to persist in treated bodies of 

water, ground water, sediments and 

bioaccumulate in animal tissues. Data 

regarding persistence of trace minerals 

resulting from uses in aquaculture are 

limited. (TR 657-659). Overall the risk of 

lethal effects from bioconcentration is 

considered low (TR685-686)

2. Is there a probability of environmental 

contamination during, manufacture or

disposal? [§6518(m)(3)]

X Industrial effluents consisting of trace 

minerals may contribute to deleterious 

growth algal blooms as found in India 

(TR810-811), but under normal regulated 

operation risks are low 

3. Are there any adverse impacts on X When used as petitioned trace minerals 

64/186
biodiversity? (§205.200) in the minute amounts used (.01-0.2% in 

feed) adverse impact on biodiversity is 

low risk

4. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

X No (TR 548)

5. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)]

X No direct interactions between trace 

minerals and other aquatic animal feed 

additives were identified (TR 825) The 

petitioned trace minerals are chemically 

equivalent to trace minerals used in 

fortification of organic livestock feed for 

terrestrial animals.

6. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518(m)(2)]

X X There is a wide range of toxicities 

associated with the range of trace 

minerals especially at excessive levels 

(TR 697-821) However a negligible 

potential for toxicity exists under the 

prescribed use. (TR 738-740)

7. Is there persistence or concentration of 

the material or breakdown products in 

the environment? [§6518(m)(2)]

X Data on persistence in aquatic systems is 

limited (TR 658) 

Overall the risk of lethal effects from 

bioconcentration of the petitioned trace 

elements is considered low. (TR 685-686)

8. Would the use of the substance be 

harmful to human health or the 

environment? [§6517 (c)(1)(A)(i); §6517 

(c)(2)(A)(i); §6518(m)(4)]

X Environmental concentrations of trace 

minerals are unlikely to cause adverse 

health effects in humans except during 

improper disposal (TR 920-926) and 

human health effects specifically related 

to trace minerals in aquatic animal feeds 

have not been reported (TR 927-928)

9. Are there adverse biological and 

chemical interactions in the agroecosystem? [§6518(m)(5)]

X No reported toxicity has been observed in 

non-target wildlife or livestock and toxicity 

in the ago-ecosystem is unlikely. 

Accidental release of industrial effluent 

may lead to ecological impairment.

10. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518(m)(5)]

X Trace elements are required by soil 

organisms, crops and livestock, so if the 

usage rates are kept within requirements 

for aquatic animals there should be no 

detrimental effects.

65/186
Category 2. Is the Substance Essential for Organic Production? Minerals (aquatic animals)

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X X Trace minerals are produced using 

chemical synthesis and extraction from 

either natural or reclaimed sources. (TR 

556-557)

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

X See 2 above

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X See 2 above

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X There are no direct substitutes for trace 

minerals (TR 993) There are natural 

sources- fish meal being the best source, 

but availability and resource demands to 

use them widely make them an 

unrealistic source. Many trace minerals 

can be found in vegetable oils, kelp, raw 

animal meat and so forth (TR 994-1044) 

Further the fish industry is working to 

mitigate demand for wild fish as fish 

feed.(TR 1068-1076)

In the early years of aquaculture raw 

horsemeat was used (TR 403-404)

6. Is there an organic substitute? 

[§205.600(b)(1)]

X

7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)] 

X X See 5 above

A combination of plant based and animal 

based feeds may meet dietary 

requirements thereby precluding 

supplementation by synthetic trace 

minerals (TR 1109-1118)

8. Are there any alternative substances? 

[§6518(m)(6)]

X See 5 above

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)]

X There is debate as to whether vitamin or 

trace minerals are necessary to meet 

nutritional requirements of farmed fish. 

(TR 1052-1054) (TR 1096)

However when fish are reared in high 

density indoor system or other closed 

systems they need to be provided with 

complete, fortified diets (TR 1096-1098)

66/186
Category 3. Is the substance compatible with organic production practices? Minerals (aquatic 

animals)

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

X Minerals are presently on the National 

List at 205.603(d)(3) and

Minerals are listed in the OFPA at 6517 

(c) (1)(B)(i)

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

X See 1 above

3. If used in livestock feed or pet food, Is 

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X Trace minerals enrich and fortify feed

4. If used in livestock feed or pet food, Is 

the primary use as a preservative? 

[§205.600(b)(4)]

X

5. If used in livestock feed or pet food, Is 

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)]

X

6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories: 

[§6517(c)(1)(B)(i); 

copper and sulfur compounds

X Some trace minerals include sulfur and 

copper compounds (TR 540-544)

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X Trace minerals

livestock parasiticides and medicines X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X

67/186
Minority Opinion - Minerals for aquatic animals

February 21, 2014 

Since this petition is being considered in the absence of regulations defining acceptable 

practices in organic aquaculture, essentiality in particular cannot be judged at this time, so the 

NOSB needs to reconsider the approval in five (5) years. The minority believes that there should 

be a five-year expiration date as an annotation. Current consideration of the material has raised 

issues relating to health or environmental impacts, because of the broad coverage of the term 

“minerals;” alternative natural materials and management methods; and compatibility with 

organic practices. The review in five (5) years provides an opportunity for the NOSB to 

reevaluate and vote for the continued or modified use of the material under the same standard 

of review that is used to approve the material initially. 

The minority also has the following concerns:

• The listing for “minerals” without qualification of either specific synthetic substance or 

specific use or application, is inconsistent with (§6517(b) of OFPA: “The list established 

under subsection (a) of this section shall contain an itemization, by specific use or 

application, of each synthetic substance permitted under subsection (c)(1) of this section 

or each natural substance prohibited under subsection (c)(2) of this section.”) 

• The listing for “minerals” includes many substances that should not be allowed in organic 

production (e.g., arsenic compounds), or used in aquatic situations (e.g., copper sulfate). 

• The listing for “minerals” without qualification or specific identification does not allow an 

informed vote on either classification or other OFPA criteria. It is impossible to judge the 

health and environmental impacts of or the need for unspecified minerals.

• The petitioner has not made a case for a need for synthetic “trace minerals” in general, 

and certainly not for synthetic “minerals.”

• It is incompatible with organic agriculture to allow the routine use of synthetic materials 

to fulfill essential system functions.

68/186
National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Vitamins in aquatic animal production

June 17 2013

Reviewed January 21, 2014 - Minor formatting revisions only

Summary of Proposed Action:

Synthetic vitamins are proposed to be added to the National List at 205.611 for use in 

production of aquatic animals. Synthetic vitamins are presently approved at 205.603(d) (3) for 

use in organic, soil based, livestock production as “Vitamins for enrichment or fortification when 

FDA approved.” Vitamins are listed in the OFPA at 6517 (c) (1) (B)(i).

Vitamins are essential for production of animals, and although feed consisting of fish meal, or 

ingredients such as soy, corn, or vegetable oils could be used to supply vitamins. Currently, 

synthetic vitamin forms provide a more readily available and consistent source of vitamins to 

ensure good health for organic livestock. In the case of nutrient requirements for fish and 

shrimp, the National Research Council (NRC) defines essential vitamin compounds as 

“required”, and it is this group of 15 synthetic vitamins which are proposed for addition to the 

National List: Vitamin A; B1 (Thiamine); B2 (Riboflavin); B3 (Niacin); B5 (Pantothenic Acid); B6 

(Pyridoxine); B7 (Biotin); B8 Choline; B9 (Folic Acid); B12 (Cobalamin); Inositol; Vitamin C; 

Vitamin D3; Vitamin E Tocopherols; and Vitamin K.

Manufacture of vitamins can be by chemical processes, fermentation or extraction depending on 

the specific vitamin. Fermentation can be synthetic or non-synthetic. Typically chemical 

processes are used to achieve consistent and balanced feed pre-mixes. While large spills 

during manufacture may result in algal blooms, the typical feeding of vitamins for fish production 

is not considered to pose environmental harm. Vitamins should not be considered persistent in 

marine environments. Adverse effects due to persistence are more likely to be seen in closed 

systems.

In considering alternative sources for the 15 vitamins petitioned, Vitamin E can be extracted 

from vegetable oils and a diet comprised of forage and fish oils is the most natural means of 

providing vitamins to carnivorous and omnivorous fish. However, the aquaculture industry is 

working to mitigate use of and possible depletion of wild fish if it continues to be used in large 

amounts as a feed source in aquaculture. Extraction from natural sources is widely considered 

inefficient and low yielding.

In reviewing whether vitamins are compatible with organic agriculture the subcommittee took 

into consideration the Organic Food Production Act (OFPA) which limits the use of synthetics to 

various categories, one of which is “pheromones, soaps, horticultural oils, fish emulsions, 

treated seed, vitamins, and minerals.

It should be noted that at the time of drafting this proposal there are no federal standards 

promulgated for aquatic plant or animal production and this proposal is based on NOSB 

Recommendations of Standards voted in 2007, 2008, and 2009.

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment x☐ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria x☐ Yes ☐ No ☐ N/A

3. Compatibility & Consistency x☐ Yes ☐ No ☐ N/A 

69/186
Substance Fails Criteria Category: [ ] Comments: N/A

Subcommittee Action & Vote, 

Classification Motion: Motion to classify vitamins, as petitioned, as synthetic: Vitamin A, 

CAS #127-47-9; B1 (Thiamine), CAS # 59-43-8; B2 (Riboflavin), CAS # 83-88-5; B3 

(Niacin), CAS # 59 67-6; B5 (Pantothenic Acid), CAS #137-08-6; B6 (Pyridoxine), CAS # 

58-56-0; B7 (Biotin), CAS # 58-85-5; B8 (Inositol), CAS # 87-89-8; B9 (Folic Acid), CAS # 

59-30-3; B12, (Cobalamin), CAS # 68-19-9; Choline, CAS # 67-48-1; Vitamin C, CAS # 50-

81-7; Vitamin D, CAS # 67-97-0; Vitamin E, Tocopherols CAS # 59-02-9; and Vitamin K, 

CAS # 130-37-0.

 

Motion by: C. Reuben Walker 

Seconded by: Jean Richardson 

Yes: 7 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

Listing Motion: Motion to list vitamins as listed above at §205.611 of the National List 

Motion by: C. Reuben Walker 

Seconded by: Jean Richardson

Yes: 7 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

 Proposed Annotation: None

Minority Opinion: see end of document

Approved by Tracy Favre, Subcommittee Chair, to transmit to NOSB January 21, 2014

NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 1. Adverse impacts on humans or the environment? Vitamins (aquatic animals) 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

X Vitamin pre-mixes are incorporated into 

feed at a rate of approximately 0.5%-

1.5% (Petition page 3) and releases are 

assumed to pose no risk (TR 982-983).

Large amounts of vitamins released into 

open waters may result in promotion of 

algal blooms and red-tides (TR 986-987) 

and perhaps eutrophication (TR 1075-

1079).

It is unlikely that vitamins use or misuse 

will result in environmental impairment 

due to their short half lives in aquatic 

systems. (TR 972-973 and 807-829).

Overall, accidental release of small 

amounts of vitamins into the environment 

70/186
is not assumed to pose any significant 

risk (TR 982-983).

2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

X See 1 above.

Industrial production of synthetic vitamins 

includes use of reagents and 

fermentation waste which can have 

negative environmental impacts, but no 

specific examples of such contamination 

are cited in TR (TR 945-987).

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X See 1 above.

4. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

X No (TR 541-548).

5. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)]

X Overall vitamins should not be 

considered persistent in marine 

environments as these compounds 

readily decompose in oxic (oxygen rich) 

environments (TR 827-829).

No direct interactions of vitamins and 

other aquatic animal feed additives have 

been identified (TR 991).

6. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518(m)(2)]

X See 5 above and 7 below.

7. Is there persistence or concentration of 

the material or breakdown products in 

the environment? [§6518(m)(2)]

X See 5 above.

The potential for toxicity is generally 

dependent on the vitamin’s solubility 

properties. Water soluble vitamins 

(thiamine, riboflavin, pyridoxine, 

pantothenic acid, niacin, biotin, folic acid, 

choline, inositol, and ascorbic acid) are 

rapidly depleted and these vitamins do 

not bioaccumulate in animal fatty tissue. 

Lipid-soluble vitamins A, D, E, and K 

bioaccumulate in fatty tissue (TR 847- 

876). Literature on bioaccumulation or 

persistence of vitamins in aquatic 

environments is limited. In general lipid 

soluble vitamins are more likely to 

bioaccumulate in fatty tissues (TR 830-

836). 

Adverse effects due to persistence will be 

more severe in closed systems (TR 805-

806).

71/186
8. Would the use of the substance be 

harmful to human health or the 

environment? [§6517 (c)(1)(A)(i); §6517 

(c)(2)(A)(i); §6518(m)(4)]

X See 1, 5, and 7 above.

Limited information is available regarding 

potential for environmental or human 

health toxicity at the small levels used 

(TR 1045-1050).

9. Are there adverse biological and 

chemical interactions in the agroecosystem? [§6518(m)(5)]

X It is unlikely that vitamins used in aquatic 

animal feed would enter a terrestrial agroecosystem (TR 1027-1028).

No studies have been found indicating 

toxic effects of vitamins in soil dwelling 

organisms (TR 1030-1033).

Vitamin D3 is used in a rodenticide 

(TR1071-1072). Overloading aquatic 

ecosystems with nutrients could 

potentially reduce BOD but this would 

negatively impact fish production and 

thus with good management can be 

avoided (TR1075-1079).

10. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518(m)(5)]

X See 1, 7, and 9 above.

No studies have been found indicating 

toxic effects of vitamins on soil-dwelling 

organisms (TR 1033).

Category 2. Is the Substance Essential for Organic Production? Vitamins (aquatic animals) 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X X There are 15 Vitamins petitioned and the 

production methods vary. Some can be 

produced by fermentation or extraction 

from natural sources, but are typically 

commercially produced by chemical 

processes (TR 553-554).

Fermentation can be considered 

synthetic or non-synthetic (TR 785-786).

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

X X See 1 above.

Of the 15 synthetic vitamins petitioned 

Vitamins A, D, E, and K are lipid (TR 852-

853). 

Vitamin E, tocopherols is typically 

extracted from natural materials, i.e. 

vegetable oils (TR 779).

72/186
Extraction from natural sources in widely 

considered inefficient and low yielding 

(TR 574-773).

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X See 1 above.

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X X See 1 and 3 above and 9 below.

6. Is there an organic substitute? 

[§205.600(b)(1)]

X X Vegetable oil for Vitamin E, but not for the 

others petitioned.

7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)]

X X For some of the vitamins vegetable oils or 

fish oils can be used.

8. Are there any alternative substances? 

[§6518(m)(6)]

X X See 1 and 8 above and 9 below.

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)]

X When possible a diet comprised of forage 

fish is the most natural means of 

incorporating proteins and vitamins into 

diets of carnivorous and omnivorous fish 

(TR 1247-1249) but the fish industry is 

working to mitigate demand for wild fish 

as fish feed (TR 1277-1285).

Category 3. Is the substance compatible with organic production practices? Vitamins (aquatic 

animals)

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

X Vitamins are presently on the National 

List at 205.603(d) (3).

Vitamins are listed in the OFPA at 6517 

(c) (1)(B)(i)

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

X See 1 above. 

3. If used in livestock feed or pet food, Is 

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X Vitamins enrich and fortify feed.

4. If used in livestock feed or pet food, Is 

the primary use as a preservative? 

[§205.600(b)(4)]

X

5. If used in livestock feed or pet food, Is 

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)]

X

73/186
6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories: 

[§6517(c)(1)(B)(i); 

copper and sulfur compounds

X X Thiamine and biotin and vitamin K are 

sulfur containing. The other vitamins 

listed do not contain sulfur (TR 537-539).

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X

livestock parasiticides and medicines X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X

74/186
National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Biologics - Vaccines in aquatic animal production

+

February 18, 2014 

Summary of Proposed Action:

Biologics – Vaccines, except for those produced by excluded methods, are proposed to be 

added to the National List at 205.611 for use in production of aquatic animals. Section 205.611 

of the National List will contain a list of synthetic substances allowed in aquatic animal 

production.

The petitioner requests vaccines (including vaccines made with excluded methods) for the 

medical treatment of aquatic animals under a new Section 205.611: Synthetic substances 

allowed for use in organic aquatic animal production (x) As ....medical treatments as applicable, 

Biologics-Vaccines.

Section 6509(d)(1)(C) of the Organic Food Production Act (OFPA) authorizes the use of 

vaccinations as an allowed healthcare practice in the production of organic livestock. 

Section 205.238(a)(6) requires that producers of land based livestock must establish and 

maintain preventive healthcare practices, including administration of vaccines and other 

veterinary biologics. At the present time organic livestock producers are allowed to use vaccines 

as provided in Section 205.603(a)(4) Biologics-vaccines. However, vaccines made with 

excluded methods (GMO) are prohibited as provided in Section 205.105 (e) However there is a

specific reference at 205.105(e) providing an allowance for vaccines made with excluded 

methods if the vaccines are reviewed and recommended for addition to the National List by the 

NOSB. Such review needs to be conducted in accordance with section 205.600(a), using 

criteria specified in the Act at 6517 and 6518. 

Products containing biologics are regulated by the USDA/APHIS Center for Veterinary biologics.

Most vaccines are injected intramuscularly or orally, although the fish can also be immersed or 

sprayed. Vaccines are composed of either weakened live or killed pathogens or antigenic 

components (molecular subunits) of pathogens. The production process begins when the 

virus/bacteria are replicated from “reference” organisms and grown in a protein growth medium 

in the laboratory. Vaccines made from excluded methods differ in that their production may be 

by altering, deleting, adding or otherwise genetically modifying the bacteria or virus. 

The Technical Report (TR) differentiates between inactivated and modified live vaccines. 

Inactivated vaccines contain microorganisms and viruses rendered non-infectious by 

inactivation. When the inactivated microorganism is bacterial the resulting vaccine is called a 

bacterin. Inactivated vaccines produced from the supernatant of a bacterial culture or from an 

inactivated toxin are called toxoids. Formaldehyde is the most widely used agent for inactivating 

viral, bacterial and parasitic pathogens. Addition of necessary adjuvants which are produced 

from a wide range of substances including oil water emulsions, aluminum containing 

compounds and various proteins. Modified live vaccines are produced in a number of ways and 

can be immunosuppressive. (TR 146-168).

Vaccines are useful in preventing or significantly reducing clinical signs and chronic conditions 

and preventing spread of disease. They are best administered in the early stage of life. If 

75/186
injected the fish may need to be sedated somewhat first as this is stressful on the fish and the 

person administering the vaccination.

Farmed fish, for example fish in net pens or tanks, are living in crowded conditions and 

vaccination is an excellent preventive for disease control, reducing disease spread into wild fish 

in the geographic area around.

Internationally vaccines are allowed in aquaculture in the UK , Canada, Japan, Sweden, except 

for GMO vaccines; The European Union allows GMO vaccines in aquaculture as an exception 

to their Rule.

Fish breeding, as with land based livestock, can be used to select highly disease resistant 

breeding lines for farming. Alternative substances and practices can be used to reduce or, in 

some cases, eliminate the need for vaccines. In the past antibiotics were administered after 

disease was noted. Fish can be fed herbal remedies or probiotics and other materials to 

stimulate their natural immune systems. Fish crowding in tanks or net pens can be reduced to 

avoid disease. Fish can be farmed in more complex multispecies environments. Constant 

monitoring of fish behavior and general health and “good husbandry” can reduce the likelihood 

of disease. Fish health in farmed facilities will be largely determined by required standards for 

organic aquaculture.

It should be noted that at the time of drafting this proposal there are no federal standards 

promulgated for aquatic plant or animal production and this proposal is based on the NOSB 

Recommendations of standards voted in 2007, 2008 and 2009.

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment x☐ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria x☐ Yes ☐ No ☐ N/A

3. Compatibility & Consistency x☐ Yes ☐ No ☐ N/A 

Subcommittee Action & Vote: 

Classification Motion: Motion to classify Biologics – Vaccines for Aquatic Animals, as 

petitioned as synthetic. 

Motion by: Jean Richardson 

Seconded by: C. Reuben Walker

Yes: 7 No: 0 Absent: 0 Abstain: 0 Recuse: 0

Listing Motion: Motion to list Biologics: Vaccines for Aquatic Animals at §205.611 with the 

following annotation: except those produced with excluded methods 

Motion by: Jean Richardson 

Seconded by: Joe Dickson

Yes: 6 No: 1 Absent: 0 Abstain: 0 Recuse: 0

Basis for annotation: x☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

 

Minority Opinion: see end of document

Approved by Tracy Favre, Subcommittee Chair to transmit to NOSB February 18, 2014

76/186
NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 1. Adverse impacts on humans or the environment? Biologics-Vaccines (aquatic animals) 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is there a probability of 

environmental contamination during 

use or misuse? [§6518(m)(3)]

X In the case of killed and modified live 

vaccines there is potential for incomplete 

inactivation for a particular vaccine lot 

leaving live pathogen and the reversion to 

virulence of the modified vaccine 

inadvertently precipitating a new epizootic 

through vaccination. But the vaccines 

themselves contain mostly organic material 

that rapidly degrades in the 

environment.(TR 656-659)

All vaccines under USDA license are 

manufactured under strictly controlled 

facilities and stringently regulated under 

EPA, thus environmentally detrimental 

waste is unlikely (TR 660-666)

Modified live vaccines are desirable and 

highly effective in closed systems. 

However the virus is still capable of 

infection. These vaccines have not usually 

been considered acceptable due to the 

environmental risk that non-virulent viruses 

could revert to virulent forms or that 

attenuated viruses that are not virulent in 

vaccinated species could prove virulent to 

other species in open systems (TR 296-

299)

Host density plays a critical role in spread 

of fish disease in the environment among 

wild and farmed fish. Low host density 

reduces rate of encounter between 

susceptible hosts and pathogens. (TR 748-

754) and thus much will depend on the 

scope and detail provided in the yet to be 

promulgated Standards for Aquaculture.

2. Is there a probability of 

environmental contamination during, 

manufacture or disposal? 

[§6518(m)(3)]

X See 1 above.

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X Because live vaccines have a short life 

span outside the host, environmental 

damage is not expected from accidental 

release or shedding from animals (Petition 

p. 10) and see 1 above.

4. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

X The substance falls into the category of a 

medicine (TR 504)

77/186
5. Is there potential for detrimental 

chemical interaction with other 

materials used in organic farming 

systems?

[§6518(m)(1)]

X Many chemicals are used in producing fish 

vaccines. Formaldehyde and 

ethyleneimine for example are not on the 

National List, yet they are presently used in 

production of approved vaccines. 

Adjuvants are added to vaccines to 

promote antigenicity and are not

considered excipients 

Polyvalent vaccines should always be used 

under veterinary supervision as adverse 

events could occur between vaccines from 

different sources.(TR 337-353)

6. Is there a toxic or other adverse 

action of the material or its 

breakdown products?

[§6518(m)(2)]

X See 1 and 5 above

Some reports have described autoimmune 

disease development in farmed salmon 

after vaccination with oil adjuvated 

vaccines. There is possibility of increased 

infection with unvaccinated pathogens as a 

result of vaccine induced autoimmunity.

Vaccines can largely reduce risks for large 

scale animal suffering caused by disease 

in fish farming.(TR 620-636)

7. Is there persistence or concentration 

of the material or breakdown 

products in the environment? 

[§6518(m)(2)]

X See 1 above

8. Would the use of the substance be 

harmful to human health or the 

environment? [§6517 (c)(1)(A)(i); 

§6517 (c)(2)(A)(i); §6518(m)(4)]

X The aim of vaccines is to prevent mass 

destruction of large numbers of infected or 

potentially contagious animals, prevent 

transmission of diseases to humans, 

promote good health of animals farmed 

and wild, and protect the environment. (TR 

300-302)

Self injection appears to be the most 

important human health risk from use of 

fish vaccines. (TR 760-761). All vaccines 

are rigorously tested in the USA.

See also 1 above

9. Are there adverse biological and 

chemical interactions in the agro-

ecosystem? [§6518(m)(5)]

X Vaccination is aimed to imitate natural 

processes in fish and have been found to 

be effective. (TR 684-712) Much depends 

on management of host density farmed in 

tanks or net pens (TR748)

There is one DNA vaccine to control an 

infectious virus (hematopoietic necrosis) 

but little is known about impacts of this in 

net pens or tanks (TR 713-727)

Ongoing research will be needed to 

evaluate impacts after regulations are 

promulgated. (TR 728-738)

10. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518(m)(5)]

X See 1 and 9 above

78/186
NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 2. Is the Substance Essential for Organic Production? Biologics-Vaccines (aquatic animals) 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X X Vaccines are created by naturally 

occurring biological processes including 

cell culture and fermentation. (TR548-

585). However, some vaccines are 

produced with formaldehyde inactivation, 

or chemical bonding with adjuvants 

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

X See 1 above

Most of the vaccines approved for use by 

the USDA for fish are produced by 

conventional methods starting from 

natural pathogens gown in culture. (TR 

73-86)

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X

6. Is there an organic substitute? 

[§205.600(b)(1)]

X

7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)]

X

8. Are there any alternative substances? 

[§6518(m)(6)]

X Host density increases the spread of 

aquatic pathogens in to and within farmed 

fish populations, and from farmed fish to 

wild fish. (TR 778-780)

There are some alternative substances, 

but probably not as effective as vaccines.

In the past farmed fish were treated with 

antibiotics when sick. Today the goal is 

prevention. Use of probiotics and feed 

additives, herbal extracts etc. can be fed 

to stimulate natural immune systems (TR 

781-806)

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)]

X See 8 above

Vaccines should only be administered to 

healthy fish. Healthy Fish populations for 

farming can be selected from certain 

breeding lines. Management and good 

husbandry can reduce possibility of 

infection both in open and closed 

systems. Disease surveillance must be a 

rigorous aspect of fish farming to avoid 

disease as far as possible.(TR 25-259)

79/186
NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 3. Is the substance compatible with organic production practices? Biologics-Vaccines 

(aquatic animals)

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

X Biologics-vaccines are allowed in land

based livestock production 

7 U.S.C.Section 6509(d)(1)(C))

7 CFR 205. 238(a)(6)

Section 205.603(a)(4)

Section 205.103(e) excludes vaccines 

made with excluded methods except as 

provided in 205.600(a), using criteria at

7 U.S.C Section 6517 and 6518

NOTE that this proposal does NOT 

propose to add to the National List any 

vaccine made with excluded methods 

(GMO)

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

X See 1 above.

3. If used in livestock feed or pet food, Is 

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X

4. If used in livestock feed or pet food, Is 

the primary use as a preservative? 

[§205.600(b)(4)]

X

5. If used in livestock feed or pet food, Is 

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)]

X

6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories: 

[§6517(c)(1)(B)(i); 

copper and sulfur compounds

X

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X

livestock parasiticides and medicines X The substances fall into the category of a 

medicine (TR 504)

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X

80/186
Minority Opinion – Biologics - Vaccines in aquatic animal production

February 21, 2014

Annotation motion for aquaculture vaccines: Add annotation, “Until May 1, 2019 [or sunset 

date].”

Justification: Since this petition is being considered in the absence of regulations defining 

acceptable practices in organic aquaculture, essentiality in particular cannot be judged at this 

time, so the NOSB needs to reconsider the approval in five (5) years. Current consideration of 

the material has raised issues relating to health or environmental impacts, especially relating to 

those in water receiving discharges or open water systems; and alterative natural materials and 

management methods. The review in five (5) years provides an opportunity for the Board to 

reevaluate and vote for the continued or modified use of the material under the same standard 

of review that is used to approve the material initially. 

In addition, the minority makes the following comments:

The answers (yes/no) checked often do not conform to the evidence presented in the 

comments/documentation column.

With regard to checklist Category 1, Adverse Impacts on Humans and the Environment, the 

minority believes the following need to be considered:

• The following statements in response to the question, “Is there a probability of 

environmental contamination during use or misuse?” suggest that the answer should be 

yes instead of no: 

o In the case of killed and modified live vaccines there is potential for incomplete 

inactivation for a particular vaccine lot leaving live pathogen and the reversion to 

virulence of the modified vaccine inadvertently precipitating a new epizootic 

through vaccination. (TR 656-659)

o Modified live vaccines are desirable and highly effective in closed systems. 

However the virus is still capable of infection. These vaccines have not usually 

been considered acceptable due to the environmental risk that non-virulent 

viruses could revert to virulent forms or that attenuated viruses that are not 

virulent in vaccinated species could prove virulent to other species in open 

systems. (TR 296-299)

• The following responses to, “Is there potential for detrimental chemical interaction with 

other materials used in organic farming systems?” suggest that the answer should be 

yes instead of no: 

o Many chemicals are used in producing fish vaccines. Formaldehyde and 

ethyleneimine for example are not on the National List, yet they are presently 

used in production of approved vaccines. Adjuvants are added to vaccines to 

promote antigenicity and are not considered excipients. (TR 338-348)

o Polyvalent vaccines should always be used under veterinary supervision as 

adverse events could occur between vaccines from different sources. (TR 349-

354)

• The following response to, “Is there a toxic or other adverse action of the material or its 

breakdown products?” suggests that the answer should be yes instead of no: 

o Some reports have described autoimmune disease development in farmed 

salmon after vaccination with oil adjuvated vaccines. There is possibility of 

increased infection with unvaccinated pathogens as a result of vaccine induced 

autoimmunity. (TR 630-634)

• The following responses to, “Are there adverse biological and chemical interactions in 

the agro-ecosystem?” indicate that not enough is known to justify the no answer:

81/186
o There is one DNA vaccine to control an infectious virus (hematopoietic necrosis) 

but little is known about impacts of this in net pens or tanks. (TR 714-728; 642-

656) 

o Ongoing research will be needed to evaluate impacts after regulations are 

promulgated. (TR 728-738)

82/186
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised January 20, 2014

National Organic Standards Board

Livestock Subcommittee

Petitioned Material Checklist

Micronutrients for use in aquatic plant production

+February 3, 2014

Summary of Proposed Action:

Micronutrients are proposed to be added to the National List at 205.609 for use in aquatic plant 

production. Section 205.609 of the National List will contain the list of synthetic substances 

allowed in organic aquatic plant production.

There are 18 to 21 elements (depending on the plant) considered essential for plants to 

properly grow and develop. Three come from air and water (C, H, O) and the rest must 

be otherwise supplied. Three are considered primary nutrients (N, P, K), three are 

considered secondary nutrients (Ca, Mg, S) and the other 12 are considered 

micronutrients: Fe, B, Cu, Cl, Mn, Mo, Zn, Co, Ni, Na, Se and Cr. Micronutrients are 

needed by plants at 10 to 100,000 times lower concentrations than primary nutrients.

Previous to the development of micronutrient media for plant aquaculture systems, it 

was common practice to add aqueous extracts of soil to culture water to supply 

micronutrients. Today, there are available micronutrient mixtures – such as the Guillard 

f/2 media – that are commonly added to culture water to supply micronutrients for plant 

aquaculture. These micronutrient mixtures generally supply six micronutrients: Fe, Cu, 

Zn, Co, Mn and Mo. However, “deficiencies of one or more additional micronutrients

may develop depending upon the source of growing water and the species of aquatic 

plant in culture” (petition, p.2).

All micronutrients are allowed for use in terrestrial organic crop production with the 

exception of those containing nitrate or chloride. In terrestrial agriculture, chloride is

avoided to avoid salt buildup in the soil. However, in aquaculture, “most water sources, 

including marine, brackish and fresh water contain much larger amounts of chloride 

salts than would be added by these nutrients at the very low levels employed” (petition, 

p. 6). None of the micronutrient formulations listed in the 2010 Micronutrient Technical 

Report for crop production (lines 59-95) contain nitrate, although several of them 

contain ammonium (a nitrogen-containing ion). However, at the low levels trace 

minerals are used at, the amount of nitrogen added with nitrogen-containing 

micronutrient supplements would be very small.

In terrestrial organic crop production, soil testing is required to document deficiencies 

before micronutrients can be applied. In aquatic plant production, micronutrients are 

generally added to culture media at the outset and supplemented occasionally, and 

“testing of dissolved ionic forms of micronutrients at very low concentrations, other than 

ferric ions, is extremely difficult or prohibitively expensive” (petition, p.4).

It should be noted that at the time of drafting this proposal there are no federal 

standards promulgated for aquatic plant or animal production and this proposal is based 

on the NOSB Recommendations voted in 2007, 2008 and 2009.

83/186
Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☒ Yes ☐ No ☐ N/A

3. Compatibility & Consistency ☒ Yes ☐ No ☐ N/A 

Substance Fails Criteria Category: [ ] Comments: NA

Subcommittee Action & Vote, 

Classification Motion: Move to classify micronutrients as petitioned for aquatic plants as 

synthetic 

Motion by: Francis Thicke 

Seconded by: C. Reuben Walker

Yes: 7 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

Listing Motion: Motion to list micronutrients at §205.609 with the following annotation: For 

non-vascular plants only.

Motion by: Francis Thicke 

Seconded by: C. Reuben Walker

Yes: 7 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

 Basis for annotation: x☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Approved by Tracy Favre, Subcommittee Chair, to transmit to NOSB February 3, 2014

NOSB Evaluation Criteria for Substances Added To the National List: Crops

Category 1. Adverse impacts on humans or the environment? Micronutrients for use in aquatic 

plant production

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

X Because micronutrients are used at very 

low concentrations there is little 

probability of environmental 

contamination. Petition (pg.4): “any 

residual trace elements released into 

environment will be extremely low 

concentrations below any physiologically 

significant level, & will be rapidly 

absorbed by microorganisms.”

84/186
2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

X Little specific information is available on 

micronutrient manufacturing in either the 

petition or TR, other than that 

micronutrients are manufactured in many 

different ways.

TR line 323: “Commercial micronutrients 

are generally manufactured as byproducts or intermediate products of

metal mining and processing industries.” 

Petition, page 3: “various trace minerals 

are obtained from sources in a number of 

countries, including China. 

Manufacturing processes are 

proprietary.” 

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X Crops TR line 534: “Micronutrients are 

essential for normal plant growth, but 

levels above that required for good 

growth can be toxic and suppress plant 

growth, and may cause adverse 

biological or chemical 

interactions in the agro-ecosystem.” 

However, there would be no incentive to 

add micronutrients at higher-than-needed 

levels for aquatic plant production.

4. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

X

5. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)] 

X TR 504-508: reactivity of micronutrients is 

low towards other chemicals/substances, 

these components exist naturally in soil; 

must follow application rates. As noted 

above, there would be no incentive to 

apply at rates higher than necessary.

6. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518(m)(2)] 

X TR 656-659: micronutrients may be 

applied as different compounds-most 

applied micronutrients are simple ionic 

forms & will not breakdown any further. 

7. Is there persistence or concentration of 

the material or breakdown products in 

the environment? [§6518(m)(2)] 

X As noted above, micronutrients are 

simple ions that will not break down 

further, and they are applied at very low 

levels, which should be expected to be 

mostly consumed by the plants.

8. Would the use of the substance be 

harmful to human health or the 

environment? [§6517 (c)(1)(A)(i); §6517 

(c)(2)(A)(i); §6518(m)(4)]

X The micronutrients used in aquatic plant 

production are also essential elements in 

humane nutrition, so at the levels used 

they will not be harmful to human health.

85/186
9. Are there adverse biological and 

chemical interactions in the agroecosystem? [§6518(m)(5)] 

X TR 545: toxicity could occur if 

micronutrients are applied in excess. 

However, in aquatic plant systems they 

are used at very low levels

10. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518(m)(5)]

X See #9 above.

Category 2. Is the Substance Essential for Organic Production? Micronutrients for use in 

aquatic plant production

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X TR line 323: “Commercial micronutrients 

are generally manufactured as byproducts or intermediate products of 

metal mining and processing industries.” 

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

X Micronutrients are manufactured in a 

wide variety of ways, generally involving 

chemical change of mineral sources.

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X See #2 above.

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X TR line 867: Most naturally available 

minerals of micronutrient components not 

soluble or are only very slowly soluble in 

water.

6. Is there an organic substitute? 

[§205.600(b)(1)]

X Minerals are inorganic

7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)]

X See #5.

8. Are there any alternative substances? 

[§6518(m)(6)]

X Micronutrients are essential elements for 

plant growth. There are no alternatives

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)]

X In some cases, recirculating water from 

other ecological systems could make 

adding micronutrients unnecessary.

86/186
NOSB Evaluation Criteria for Substances Added To the National List: Crops/Livestock

Category 3. Is the substance compatible with organic production practices? Micronutrients for 

use in aquatic plant production 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

X

2. Is the substance compatible with a 

system of sustainable agriculture?

[§6518(m)(7)]

X

3. If used in livestock feed or pet food, Is 

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X

4. If used in livestock feed or pet food, Is 

the primary use as a preservative? 

[§205.600(b)(4)]

X

5. If used in livestock feed or pet food, Is 

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)]

X

6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories:

[§6517(c)(1)(B)(i); 

copper and sulfur compounds

X

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X

livestock parasiticides and medicines X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X

87/186
88/186
National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Carbon Dioxide (CO2) for Use in Aquatic Plant Production

+

February 3, 2014

Summary of Proposed Action:

Synthetic carbon dioxide is proposed to be added to the National List at 205.609. 

Section 205.609 will contain a list of synthetic substances allowed in organic aquatic 

plant production.

Carbon dioxide is an inorganic compound composed of one carbon atom and two 

oxygen atoms. In nature, carbon dioxide occurs as a gas and comprises 0.03% of the 

Earth’s atmosphere. It is utilized by plants during photosynthesis and is produced by 

respiration by animals and plants. It is an important component of the carbon cycle and 

is also a well-known greenhouse gas. 

The petition is for the use of carbon dioxide to grow algae within contained systems 

such as ponds and tanks. Petitioned use is for synthetic carbon dioxide due to the 

difficulty in buyers determining the source of CO2. However there are naturally 

occurring sources of CO2 available in some parts of the country. 

CO2 gas is used in the culture of aquatic plants as a production aid for alkalinity 

adjustment and maintaining pH at levels essential for rapid and healthy growth of the 

algae. Most, if not all, algae species are sensitive to pH levels. Carbon dioxide is used 

to maintain desired pH levels in water. The addition of CO2 to water drives the pH value 

lower. Carbon dioxide is consumed by algae as cultures grow and can drive the pH 

level above the desired optimum. Since aquatic animals eliminate carbon dioxide as a 

metabolic product, the presence of aquatic animals in an algal culture reduces demand 

for carbon dioxide.

Carbon dioxide is available from natural sources and as a byproduct of various artificial 

sources. The most common operations from which commercially produced carbon 

dioxide is recovered are industrial plants which produce hydrogen or ammonia from 

natural gas, coal, or other hydrocarbon feedstock, and large-volume fermentation 

operations in which plant products are made into ethanol for human consumption, 

automotive fuel or industrial use. Breweries producing beer from various grain products 

are a traditional source. Corn-to-ethanol plants have been the most rapidly growing 

source of feed gas for CO2 recovery.

Carbon dioxide is allowed for use under all international organic standards that were 

researched in an August 2006 technical report including Canadian, CODEX, EEC 

Council and IFOAM. However, it should be noted that at the time of that technical 

report, organic standards were not in place for organic aquatic plant production, and the 

allowed uses of carbon dioxide were for processing aids, pest control and terrestrial 

plant production. 

89/186
While the petition is for synthetic carbon dioxide, the petitioner has made it clear that the 

reason for the request to include synthetic CO2 is because of the variable availability 

around the country, rather than because synthetic is the only source. 

Per the 1995 NOSB TAP review, CO2 poses little risk to the environment and was 

unanimously determined to be consistent with a system of sustainable agriculture. At 

that time, the petitioned use was for addition to the National List at 205.605 for use in 

organic handling. The present petition is for use in aquatic plant production and 

therefore should be evaluated with different considerations. It could be argued that 

production methods that require continued external inputs may not be sustainable. 

It should be noted that at the time of drafting this proposal there are no federal 

standards promulgated for aquatic plant or animal production and this proposal is based 

on NOSB recommendations of standards voted in 2007, 2008, and 2009.

 

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment X Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria X Yes ☐ No ☐ N/A

3. Compatibility & Consistency X Yes ☐ No ☐ N/A 

Substance Fails Criteria Category: [ ] Comments: 

Subcommittee Action & Vote, including classification proposal (state actual motion):

Classification Motion: Motion to classify Carbon Dioxide, CAS # 124-38-9, as synthetic 

Motion by: Tracy Favre 

Seconded by: Joe Dickson

Yes: 5 No: 0 Absent: 2 Abstain: 0 Recuse: 0 

Listing Motion: Motion to list CO2 at §205.609 with the following annotation: for use in 

contained systems such as tanks and ponds. 

Motion by: Tracy Favre 

Seconded by: Calvin Walker

Yes: 4 No: 1 Absent: 2 Abstain: 0 Recuse: 0 

Basis for annotation: X To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Minority Opinion: see end of document

Approved by Tracy Favre, Subcommittee Chair, to transmit to NOSB February 3, 2014

90/186
NOSB Evaluation Criteria for Substances Added To the National List: Crops

Category 1. Adverse impacts on humans or the environment? Carbon Dioxide for use in 

Aquatic Plant Production 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

X Carbon dioxide can be classified as either 

synthetic or non-synthetic depending 

upon source, and is a naturally occurring 

component of air. High concentrations 

can lower the pH of water, which could 

adversely affect the environment. 

However, good management practices 

would mitigate this possibility. (Petition 

2012).

2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

X. Production of carbon dioxide is a byproduct of processes that have adverse 

effects on the environment. However, 

because CO2 is a by-product of these 

processes, these affects would occur 

regardless of CO2 production. (Aug 2006 

TR, lines 296-299). 

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X Under good management practice carbon 

dioxide for use in aquatic plant production 

is self-limiting, as too much CO2 

decreases plant production and lowers 

water pH. (Petition, 2012) So impacts to 

biodiversity are unlikely. 

4. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

X CO2 can exist in gaseous, liquid or solid 

forms but does not contain inerts. All 

manufacturing processes require 

purification (Aug 2006 TR, lines 188-189)

5. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)] 

X High concentrations of CO2 will decrease 

water pH and make some nutrients biounavailable, but under normal good 

management practices, it is unlikely there 

would be detrimental chemical 

interactions. (Petitioner) See #3 above 

regarding self-limiting.

6. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518(m)(2)] 

X CO2 can be long-lived in the environment 

and therefore could contribute to climate 

change but otherwise poses no adverse 

action upon breakdown. 

7. Is there persistence or concentration of 

the material or breakdown products in 

the environment? [§6518(m)(2)]

X Carbon dioxide is a greenhouse gas (Aug 

2006 TR, line 299), however, under 

proper management for aquatic plant 

production, CO2 would be metabolized by 

aquatic plants. (Petitioner)

91/186
8. Would the use of the substance be 

harmful to human health or the 

environment? [§6517 (c)(1)(A)(i); §6517 

(c)(2)(A)(i); §6518(m)(4)]

X At levels proposed for use by the 

petitioner, under normal good 

management practice, there is no 

demonstration of harmful effects to 

human health or the environment. In high 

concentrations in closed systems, there is 

a possibility of atmospheres dangerous 

for humans, but good management 

practices are likely to mitigate this 

possibility. Up to .05% is considered not 

harmful to humans. However, higher 

concentrations can be harmful. (Aug 

2006 TR, lines 306-307) No evidence 

was found indicating that carbon dioxide 

leaves residues on food. (Aug 2006 TR, 

lines 354-356). Carbon dioxide is on the 

list of FDA confirmed GRAS substances. 

(Aug 2006 TR, lines 348-349)

9. Are there adverse biological and 

chemical interactions in the agroecosystem? [§6518(m)(5)] 

X On the contrary, good management of 

CO2 levels leads to increased plant 

production and biodiversity. Only at high 

concentrations could CO2 potentially have 

a negative impact. (Petitioner)

10. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518(m)(5)]

X See comment above.

Category 2. Is the Substance Essential for Organic Production? Carbon Dioxide for Use in 

Aquatic Plant Production 

 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X Carbon dioxide is an inorganic compound 

composed of one carbon atom and two 

oxygen atoms. In nature, carbon dioxide 

occurs as a gas and comprises 0.03% of 

the Earth’s atmosphere. It is utilized by 

plants during photosynthesis and is 

produced by respiration by animals and 

plants. It is an important component of 

the carbon cycle and is also a well known 

greenhouse gas. (Aug 2006 TR, lines 

17-21) Petitioned use is for synthetic 

Carbon Dioxide due to the difficulty in 

buyers determining the source of CO2. 

However, while non-agricultural, there are 

naturally occurring sources of CO2 

available in some parts of the country. 

(Aug 2006 TR, lines 240-252)

92/186
2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X There are numerous methods by which 

CO2 can be produced, including 

fermentation and as a by-product of oil 

and gas production. (Aug 2006 TR, lines 

226-229)

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

X In some cases, CO2 production is a result 

of manufacturing processes, such as 

ethanol or oil and gas refining processes. 

(Aug 2006 TR, lines 178-201)

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X CO2 can result from metabolic process of 

plants and animals and from some 

fermentation processes. (Aug 2006 TR, 

lines 203-207, 234-238)

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X Naturally occurring CO2 does exist in 

deposits located in Mississippi, Colorado, 

and New Mexico, Utah, Wyoming and 

Washington, but transport of pressurized 

gas over long distances is not advised, 

and therefore may not be available in 

some parts of the country. (Aug 2006 

TR, lines 178-201)

6. Is there an organic substitute? 

[§205.600(b)(1)]

X Citric acid can be used in soil based 

operations but for aquatic environments, 

there is no known substitute. (Petitioner)

7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)] 

X Naturally occurring as a result of 

biological processes of animals, 

additionally natural sources of CO2 are 

available on a regional basis. (Petitioner)

8. Are there any alternative substances? 

[§6518(m)(6)] 

X There are no known substitutes. While 

there are non-synthetic forms of 

carbonate such as sodium bicarbonate 

and sodium carbonate that can lower pH 

values in water, these substances do not 

lower pH to values below 8.5 that are 

necessary for most species of algae. For 

aquatic plant production, CO2 is essential 

for proper plant health and productivity. 

When aquatic plant production is paired 

with animal production, the requirement 

for additional CO2 is reduced. (Petitioner)

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)]

X See comment #8 above, however it is 

difficult to properly maintain water pH in 

aquatic plant production without the use 

of CO2 . Alkalinity and pH control is 

essential in the culture of aquatic 

systems. All, or virtually all, aquatic plants 

require carbon dioxide for healthy and 

rapid growth. There are no substitute 

substances, nor are there alternative 

culture methods. (Petitioner)

NOSB Evaluation Criteria for Substances Added To the National List Crops

93/186
Category 3. Is the substance compatible with organic production practices? Carbon Dioxide 

for Use in Aquatic Plant Production 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)] 

X Per a 2005 TAP review, CO2 is 

consistent with organic farming and 

handling. CO2 is already listed on the 

National List for use in organic handling 

at 205.605. Carbon dioxide is allowed for 

use under all international organic 

standards that were researched including 

Canadian, CODEX, EEC Council and 

IFOAM. However, it should be noted that 

at the time of the technical report, organic 

standards were not in place for organic 

aquatic plant production, and the allowed 

uses of carbon dioxide were for 

processing aids, pest control and

terrestrial plant production (Aug 2006 TR, 

lines 127-171)

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

X X Per the 1995 NOSB TAP review, CO2 

poses little risk to the environment and 

was unanimously determined to be 

consistent with a system of sustainable 

agriculture. At that time, the petitioned 

use for or addition to the National List at 

205.605(b) for use in organic handling. 

The present petition is for use in aquatic 

plant production and therefore should be 

evaluated with different considerations. 

While the petition is for synthetic Carbon 

Dioxide, the petitioner has made it clear 

that the reason for the request to include 

synthetic CO2 is because of the variable 

availability around the country, rather 

than because synthetic is the only 

source. It could be argued that 

production methods that require 

continued external inputs may not be 

sustainable. 

3. If used in livestock feed or pet food, Is 

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X

4. If used in livestock feed or pet food, Is 

the primary use as a preservative? 

[§205.600(b)(4)]

X

94/186
5. If used in livestock feed or pet food, Is 

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)]

X

6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories:

[§6517(c)(1)(B)(i); 

copper and sulfur compounds

X

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X

livestock parasiticides and medicines X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X

Minority Opinion - Carbon Dioxide for Use in Aquatic Plant Production

February 23, 2014

A minority of the subcommittee suggests that it is appropriate to adopt an annotation for carbon 

dioxide in aquaculture, with a justification explaining the that the specific time frame of five (5) 

years for an expiration date allows the Board to monitor the use of the material, incentivize 

alternatives, update its scientific and essentiality review, and vote on the continuation of use 

pending the receipt of a petition requesting that use be continued.

Support for the annotation is based on the following justification: Since this petition is being 

considered in the absence of regulations defining acceptable practices in organic aquaculture, 

essentiality in particular cannot be judged at this time. Therefore, the NOSB needs to reconsider 

the approval in five (5) years at the least. Current consideration of the material has raised issues 

relating to health or environmental impacts; alternatives derived from natural sources; and 

compatibility with organic and sustainable agriculture.. The review in five (5) years provides an 

opportunity for the Board to reevaluate and vote for the continued or modified use of the 

material under the same standard of review that is used to approve the material initially. 

The NOSB Principles of Organic Production and Handling (adopted October 17, 2001) begin:

 

Organic agriculture is an ecological production management system that promotes and 

enhances biodiversity, biological cycles, and soil biological activity. It emphasizes the use of 

management practices in preference to the use of off-farm inputs, taking into account that 

regional conditions require locally adapted systems. These goals are met, where possible, 

95/186
through the use of cultural, biological, and mechanical methods, as opposed to using synthetic 

materials to fulfill specific functions within the system.

To provide a major component necessary for aquatic plant growth in the form of a synthetic 

chemical is inconsistent with organic principles.

The Crops Subcommittee received information that indicates that additions of synthetic carbon 

dioxide are not essential. An NOP survey of certifiers who certify organic aquatic plant 

production found that very few inputs were used. Sometimes natural alkali, carbon dioxide, and 

sodium bicarbonate were used. Integrated systems1 control pH and alkalinity, as well as other 

parameters, by balancing the organic components of the system.

While carbon dioxide may not seem very hazardous, the atmospheric concentration has 

reached the all-time high of 400ppm, elevating to extreme levels the threat of global climate 

change. Organic production may not be a large contributor, but the use of synthetic carbon 

dioxide, which is not captured, as opposed to using carbon dioxide produced by animals in the 

system, does contribute to the problem.

Finally, lacking an organic aquaculture policy for plant production introduces a further difficulty in 

creating the parameters necessary to establish systems that are compatible with the Organic 

Foods Production Act and resulting organic methods. Evaluating the use patterns of synthetic 

materials permitted on the National List outside of a defined policy on whole aquaculture 

systems for plants and animals runs contrary to organic process and practice because the use 

of a synthetic material must be evaluated relative to a practice norm in which no synthetics are 

added. 

The petitioner has indicated that carbon dioxide for use in organic production of aquatic plants 

would be used only in closed systems. We believe that use of this substance in closed systems 

with no discharge to natural water bodies is vital to be added to the motion for the carbon 

dioxide proposed recommendation.

1 See, for example, Siew-Moi Phang, 1992. Role of algae in livestock-fish integrated farming systems. 

Proceedings of the FAO/IPT Workshop on Integrated Livestock-Fish Production Systems, 16–20 

December 1991, Institute of Advanced Studies, University of Malaya, Kuala Lumpur, Malaysia.

96/186
National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Chlorine Materials in Aquatic Plant Production

+

February 18, 2014

Summary of Proposed Action:

Chlorine Materials are petitioned for use in aquatic plant production, to be added to 205.609 - 

Synthetic substances allowed for use in organic aquatic plant production as follows:

§ 205.609 Synthetic substances allowed for use in organic aquatic plant production. 

(a) As disinfectants and sanitizers. 

(x) Chlorine materials— Except, That, residual chlorine levels in water shall not 

exceed the maximum residual disinfectant limit under the Safe Drinking Water 

Act 

(i) Calcium hypochlorite 

(ii) Chlorine dioxide 

(iii) Sodium hypochlorite

Chlorine materials are widely used for their disinfectant properties, and are currently approved 

for such uses in crop, livestock and processed organic product production. The annotations on 

the National List for livestock and handling limit the use of chlorine materials to disinfection and 

sanitation, and require that residual chlorine levels be consistent with Safe Drinking Water Act 

levels. The current listing for use in crops at 205.601(a) states:

(2) Chlorine materials—For pre-harvest use, residual chlorine levels in the water in direct 

crop contact or as water from cleaning irrigation systems applied to soil must not exceed 

the maximum residual disinfectant limit under the Safe Drinking Water Act, except that 

chlorine products may be used in edible sprout production according to EPA label 

directions.

(i) Calcium hypochlorite.

(ii) Chlorine dioxide.

(iii) Sodium hypochlorite.

The NOP has also clarified the use of chlorine in production and handling in a guidance 

document, NOP 5026.

The Livestock and Crops Subcommittees have received a petition for the use of Chlorine 

Materials in aquatic livestock and plant production. This checklist and proposal relate to the 

proposed use in aquatic plant production; a separate checklist evaluates the petitioned use in 

aquatic animal production. These materials are used in aquatic plant production for the 

disinfecting hard surfaces and culture water in nurseries, growout operations with tanks, harvest 

equipment, and in processing facilities. Because the petitioned uses of chlorine are identical for 

aquatic plants and animals, this checklist follows the same logic as the Livestock Subcomittee’s 

proposal for chlorine in aquatic animal production. Given that the materials’ use in aquaculture 

applications is identical to existing uses in other production categories, the Livestock committee 

did not requested a new Technical Evaluation Report for the petitioned use in aquatic animal 

production, but instead relied upon recent TR’s developed for Handling and Crops uses of this 

group of materials. The crops committee did request a TR for chlorine as part of the 2012 

sunset review of the material, and that 2011 TR has be utilized in the preparation of this 

checklist. 

97/186
During the subcommittee discussion and vote, several members raised concerns as to whether 

the petition and technical review adequately address the question of whether this material is 

essential in aquatic plant production, or whether functional and commercially viable alternative 

disinfectants and sanitizers exist. The subcommittee specifically requests public comment from 

any knowledgeable stakeholders in this particular area. 

It should also be noted that at the time of drafting this proposal there are no federal standards 

promulgated for aquatic plant or animal production and this proposal is based on the NOSB 

Recommendations of standards voted in 2007, 2008 and 2009.

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? 

1. Impact on Humans and Environment X Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria X Yes ☐ No ☐ N/A

3. Compatibility & Consistency X Yes ☐ No ☐ N/A 

as Organic (only for § 205.606)

Proposed Annotation (if any): see listing motion below

Basis for annotation: X To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: This annotation is consistent with other listings of Chlorine on the NL, and ensures 

that any environmental impact is effectively mitigated. 

Recommended Subcommittee Action & Vote, including classification recommendation (state 

actual motion):

Classification Motion: Chlorine Materials (Calcium hypochlorite, chlorine dioxide, sodium 

hypochlorite) are synthetic.

Motion by: Joe Dickson

Seconded by: Colehour Bondera

Yes: 7 No: 0 Absent: 0 Abstain: 0 Recuse: 0

Listing Motion: Motion to list chlorine materials (Calcium hypochlorite, chlorine dioxide, 

sodium hypochlorite) at §205.609 with the following annotation: Chlorine materials - 

Disinfecting and sanitizing facilities and equipment. Residual chlorine levels in the water 

shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act.

Motion by: Joe Dickson

Seconded by: Jean Richardson

Yes: 6 No: 1 Abstain: 0 Absent: 0 Recuse: 0 

Minority Opinion: see end of document

Approved by Tracy Favre, Subcommittee Chair, to Transmit to NOSB February 23, 2014

98/186
NOSB Evaluation Criteria for Substances Added To the National List: Crops

Category 1. Adverse impacts on humans or the environment? Chlorine Materials

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

X 2006 Crops TR lines 212-266. The TR 

identities several areas of potential 

environmental impact, but notes that 

existing EPA regulations and the 

annotation restricting effluent to the levels 

of the Safe Drinking Water Act are 

sufficient to mitigate any environmental 

impact. The petitioner and a number of 

producers have confirmed that chlorine 

materials are not used in direct contact 

with the environment (e.g. ponds and net 

pens) and the restrictive annotation would 

prohibit such uses regardless. 

The 2011 Crops TR (lines 225-306) is 

consistent with the 2006 TR. 

2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

X See Question 1

3. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

X No. [2006 Crops TR; 2011 Crops TR ]

4. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)]

X The annotation restricts use to levels no 

greater than those determined by the 

Safe Drinking Water Act, so the potential 

for detrimental chemical interaction is 

similar to that posed by municipal tap 

water. 

5. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518(m)(2)] 

X The annotation restricts use to levels no 

greater than those determined by the 

Safe Drinking Water Act, so the potential 

for detrimental chemical interaction is 

similar to that posed by municipal tap 

water. Any presence of the substance in 

the overall agroecosytem would be 

required by the annotation to meet the 

requirements of the Safe Drinking Water 

Act, ensuring presence below 4 ppm.

99/186
6. Is there persistence or concentration of 

the material or breakdown products in 

the environment? [§6518(m)(2)] 

X No. The substance degrades rapidly to 

naturally occurring compounds in the 

presence of air and sunlight [2006 Crops 

TR 417-432] This TR also confirms (in 

lines 384 –402) that these materials are 

not persistent in the environment in 

general, and that in water and soil, 

sodium and calcium hypochlorite 

separate into sodium, calcium and 

hypochlorite ions. Chlorine dioxide is also 

reactive and breaks down quickly. While 

the TER does not directly address its fate 

in aquatic environments, again, the 

annotation would limit the extent to which 

any chlorine material could be discharged 

into sea water or any other part of the 

environment.

The 2011 Crops TR (lines 381-390) is 

consistent with the 2006 TR. 

7. Would the use of the substance be 

harmful to human health or the

environment? [§6517 (c)(1)(A)(i); §6517 

(c)(2)(A)(i); §6518(m)(4)]

X See Q # 1

8. Are there adverse biological and 

chemical interactions in the agroecosystem, including biodiversity? 

[§6518(m)(5)]

X Any presence of the substance in the 

overall agroecosytem would be required 

by the annotation to meet the 

requirements of the Safe Drinking Water 

Act, ensuring presence below 4 ppm. 

9. Are there detrimental physiological 

effects on soil organisms, crops, or

livestock? [§6518(m)(5)]

X The substance is not used in direct 

contact with soil or terrestrial livestock. It 

is only used in contact with hard surfaces 

and equipment, or culture water. [2006 

Crops TR 322-327, petition]

Category 2. Is the Substance Essential for Organic Production? Chlorine Materials 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X Yes. 2006 TR Lines 149-171. 2011 TR 

Lines 183-211.

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

X This process does not involve the 

chemical transformation of a natural 

substance; the starting materials are 

synthetic. 2006 TR Lines 177-178. 2011 

TR Lines 216-217.

100/186
4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X 2006 TR Lines 183-184. 2011 TR Lines 

222-223.

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X 2006 TR Lines 183-184. 2011 TR Lines 

222-223.

6. Is there an organic substitute? 

[§205.600(b)(1)]

X 2006 TR Lines 183-184. 2011 TR Lines 

222-223.

7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)] 

X While the 2011 TR does list a number of 

potential alternatives (lines 519-530), the 

petition (pages 7-8) describes compelling 

limitations of the alternatives. 

8. Are there any alternative substances? 

[§6518(m)(6)]

X See #7

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)]

X 2011 TR Lines 611-628. None of the 

alternatives are effective for cleaning 

irrigations systems. 

Category 3. Is the substance compatible with organic production practices? Chlorine Materials

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)] 

X The evaluation criteria above shows that 

the material is essential in organic 

aquatic plant production and, as 

petitioned, does not present adverse 

effects on humans or the environment. 

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)] 

X See #1

3. If used in livestock feed or pet food, Is 

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)] 

X

4. If used in livestock feed or pet food, Is 

the primary use as a preservative? 

[§205.600(b)(4)] 

X

5. If used in livestock feed or pet food, Is 

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)] 

X

101/186
6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories:

[§6517(c)(1)(B)(i); 

copper and sulfur compounds

X

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X

livestock parasiticides and medicines X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers 

X

Minority Opinion - Chlorine Materials in Aquatic Plant Production

February 20, 2014

A minority of the subcommittee suggested that the subcommittee adopt an annotation motion 

for chlorine use in aquaculture for plants that set a 5-year expiration date on the listing, with a 

justification explaining that the specific time frame for an expiration date allows the Board to 

monitor the use of the material, update its scientific and essentiality review, incentivize 

alternatives and continuous improvement, and vote on the continuation of use pending the 

receipt of a petition requesting that use be extended.

Support for the annotation motion is based on the following justification: Since the petition for 

chlorine use in aquaculture certified organic is being considered in the absence of regulations 

defining acceptable defined practices in organic aquaculture, essentiality in particular cannot be 

judged at this time. Therefore, the NOSB needs to reconsider the approval in five years at the 

least. Current consideration of the material has raised issues relating to health or environmental 

impacts, especially relating to chlorine manufacture; alternatives under consideration by EPA’s 

Design for the Environment and the Toxics Use Reduction Institute; and compatibility with 

organic and sustainable agriculture. The review in 5 years provides an opportunity for the Board 

to reevaluate and vote for the continued or modified use of the material under the same 

standard of review that is used to approve the material during its petition review. 

In addition, the minority makes the following comments and additions to the majority checklist, 

which it believes does not provide a full assessment of environmental and health standards 

review required under the Organic Foods Production Act (OFPA): There are two separate uses 

covered by the petition – (1) disinfection of hard surfaces, and (2) disinfection of culture water. 

These two uses are distinct, and the distinction is blurred by the motion of the subcommittee. 

The use for disinfecting hard surfaces is similar to the allowed use in terrestrial crop production. 

It is specifically mentioned as a use included as a “production aid” in OFPA. Such use results in 

limited effluent, and the major difference between it and the current §601 listing is that 

aquaculture facilities are likely to be closer to water that could be contaminated by effluent. The 

use for disinfecting culture water, on the other hand, involves much greater quantities of water, 

102/186
potentially larger discharges, and the possibility for spills into waterbodies. It is not a “production 

aid” use. The Technical Review (TR) does not address hazards associated with such a use in 

questions #4-8. Alternatives for the water disinfection use are not discussed in questions #12-

14. We cannot be sure what such a use would be in the aquaculture setting until we have 

aquaculture standards (for example, what is the agro-ecosystem in question?)

With regard to alternatives, there are now resources associated with “Green Chemistry” 

programs, such as the Toxics Use Reduction Institute at the University of Massachusetts in 

Lowell, and the Design for the Environment program at EPA that address chemical alternatives 

to chlorine as a disinfectant when such nonchemical approaches as steam are not appropriate. 

These need to be considered in evaluating alternatives. See, for example, the following 

websites: The Presidential Green Chemistry Challenge Awards Program p. 30 (p. 34 of pdf);

Overview of Design for the Environment, disinfectants p. 20; Green Product Certification and 

Labeling: Quick Reference. 

Further, the petitioner has indicated that all materials petitioned for use in organic production of 

aquatic plants would be used only in closed systems. Therefore, an annotation should be added 

restricting the use of chlorine to closed systems with no discharge into natural waterbodies.

With regard to checklist Category 1, Adverse Impacts on Humans and the Environment, the 

minority believes the following need to be considered:

• Effluent standards are set under the Clean Water Act (CWA), so there is a disconnect 

between allowances under the SDWA and impacts on wildlife under the CWA. The 

SDWA standard of 4 mg/L is 363 times as high as the aquatic life protection criterion of 

11 ug/L set under the CWA.1 Neither, however, equates to the OFPA criterion of “no 

harm” and the fact that aquaculture systems are closer to water that could be 

contaminated by effluent than terrestrial agricultural systems raises unique concerns that 

require close scrutiny and not reliance on other standards for terrestrial production. 

• Misuse can kill plants and soil organisms and raise soil pH and kill fish and invertebrates 

(2011 Crops TR lines 386-390; 270-271)

• TRI data includes 5.7 million pounds of chlorine per year released by facilities making 

and using chlorine. (ATSDR Tox Profile p. 162) 

• When mixed with organic materials (e.g., algae, dirt), hypochlorite produces 

trihalomethanes (THMs), which are carcinogenic. Currently, the maximum contaminant 

level (MCL) for total THMs is 0.080 mg/L (EPA 2009). (2011 Crops TR lines 277-280) 

Depending on the source of water, this could result in the presence of THMs in culture 

water and its concentration in algae when used to disinfect water. (Chloroform MSDS 

http://datasheets.scbt.com/sc-239527.pdf) 

• Due to high reactivity, the petitioned substances do not persist in the environment. But 

many products are possible from reactions, and some may be persistent. This is 

particularly an issue for water disinfection. (2011 Crops TR lines 476-491)

• Human health effects of chlorine include burning, pain, inflammation, irritation to 

respiratory system, etc. (2011 Crops TR lines 496-514)

• Chlorine may harm the beneficials inherent in an aquaculture system when used to 

disinfect water, or when discharged. (2011 Crops TR, lines 270-271)

• Chlorine compounds are used to kill algae, an important part of the aquatic ecosystem. 

(2011 Crops TR, lines 62, 87) 

1 EPA Ambient Water Quality Criteria for Chlorine, 

http://water.epa.gov/scitech/swguidance/standards/upload/2001_10_12_criteria_ambientwqc_chlorine198

4.pdf 

103/186
With regard to checklist Category 2, Essentiality, the minority believes the following need to be 

considered:

• “[T]he following non-synthetic materials are allowed as drip irrigation cleaners and could 

be used on hard surfaces: acetic acid, vinegar, citric acid, and other naturally occurring 

acids.” (2011 Crops TR 519-520) 

• The petition does not describe any limitations of alternative substances. It simply states 

that the alternatives are not used. The petition also does not distinguish between the 

disinfection of equipment and water. Some alternatives may be useful for one and some 

the other.

• Other alternative substances are hydrogen peroxide, electrolyzed water, alcohols, 

peracetic acid, copper sulfate, and soap algaecides for hard surfaces. Ozone for water 

disinfection (2011 Crops TR 535-606) See EPA Green Chemistry award for 

alternatives.2

• For other practices, see Toxics Use Reduction Institute CleanerSolutions Database.3

Under Category 3, Compatibility, the minority points out the following:

• Chlorine does not enhance water life and properties; is not from renewable resources; 

and has negative impacts on biodiversity. (2011 Crops TR 270-271, 278-279, 349-352).

• Natural alternatives exist. (2011 Crops TR 270-271, 278-279, 349-352, 519-530)

• The use for culture water disinfection is not included in any of the OFPA categories of 

§6517(c)(1)(B)(i). 

2 The Presidential Green Chemistry Challenge Awards Program Summary of 2005 Award Entries and 

Recipients, p. 30. http://www.epa.gov/greenchemistry/pubs/docs/award_entries_and_recipients2005.pdf

Almost all traditional, widely used disinfecting and sanitizing products contain ingredients that are toxic or 

potentially toxic, are environmentally hazardous, or have a high potential for accidents. For example, 

oxidizing chemicals, such as hypochlorite, peracetic acid, hydrogen peroxide, ozone, and chlorine 

dioxide, kill microorganisms by indiscriminate oxidation of organic matter, potentially destroying 

antioxidants, nutrients, and vitamins while forming unknown or toxic byproducts, including cancer-causing 

free radicals. The non-oxidizing microbicidal quaternary ammonium compounds (QACs; other traditional 

disinfectants) inhibit butyl cholinesterase in blood plasma, liver, pancreas, and the white matter and are 

unsafe for use on fruits and vegetables because they leave large residues. 

Microcide uses ingredients listed by the FDA and EPA in volumes 21 and 40 of the Code of Federal 

Regulations (CFR) as biodegradable, generally recognized as safe (GRAS), food additives, safe, and/or 

nonpolluting. With these ingredients, Microcide develops broad-spectrum microbicidal products as 

alternatives to toxic and oxidizing chemicals for the food processing, personal care, and health industries. 

Their products use surface-active agents at low pH. Raising the pH diminishes the microbicidal 

properties, allowing safe environmental disposal and biodegradation of the products after use. These 

products selectively kill microorganisms on food-contact surfaces, on fresh fruits and vegetables, and on 

body parts (including mucosal and skin surfaces) without covalent chemical reactions. The technology 

presents alternative products safe for manufacturing, transportation, and use without accident potential. 

Two of Microcide’s products, PRO-SAN and PRO-SAN L, are EPA-registered pesticides. 3 http://www.turi.org/Our_Work/Cleaning_Laboratory/Does_It_Clean/CleanerSolutions_Database

104/186
National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Lignin Sulfonate in aquatic plant production

+

January 21, 2014

Summary of Proposed Action:

Synthetic lignin sulfonate is proposed to be added to the National List at 205.609 for use only as 

a chelating agent for micronutrients used in aquatic plant production. Section 205.609 of the 

National List will contain the list of synthetic substances allowed in organic aquatic plant 

production. 

Synthetic lignin sulfonate is presently approved for use in organic (soil based) crop production 

as a plant or soil amendment (chelating agent), and as a dust suppressant 205.601(j)(4), and as 

a floating agent in post-harvest handling (205.601(l)(1)). 

Chelating agents are water soluble compounds that have the ability to bind with metal nutrients. 

The soluble nature of the chelate molecule facilitates root and cell uptake of metal nutrients. 

Because most micronutrients are metals (e.g., iron, cobalt, zinc, etc.), many fertilizers with 

micronutrients contain some form of chelating agent.

Micronutrients are essential nutrients to maintain growth, maturation and disease resistance. 

Micronutrients must be chelated to become available for aquatic plants. Mineral deficiencies 

result from inadequate intake and lead to poor plant growth.

Lignin sulfonate is a by-product of the wood pulping industry. It is a derivative of lignin, where 

lignin has been sulfonated in the wood pulping process. There are a number of methods for 

pulping wood, such as sulfite chemical pulping, the acidic sulfite process, and the Kraft pulping 

process. Typically the process consists of cooking softwood chips under pressure in sulfur 

dioxide–containing liquors. Sulfonated lignin is the liquid by-product in the spent liquor when the 

pulping process is complete.

Although “Lignin Sulfonate” is the petitioned material it actually complexes into several salts, 

each with a separate CAS number, namely: sodium lignosulfonate; magnesium lignosulfonate; 

ammonium lignosulfonate; and calcium lignosulfonate. The Organic Materials Review Institute 

(OMRI) places restriction on use of ammonium lignosulfonate, but otherwise lignin sulfonate can 

be used with any allowed micronutrient. Petitioner requests addition to National List of sodium 

lignosulfonate with CAS numbers 8061-51-6 and 9009-75-0, and lignin sulfonic acid, CAS 8062-

15-5 which forms a “sulfonate” when chelated to a metal.

Lignin sulfonate salts are soluble in water. Due to their high biological demand (BOD) during 

breakdown in water, lignosulfonates will remove dissolved oxygen from waterways, and 

decreased pH may result from lignin sulfonate decomposition in water. Lower pH levels can 

increase the level of some metals, such as mercury, in aquatic systems leading to higher 

exposures in fish. However, when lignin sulfonates are used as chelating agents to bind 

micronutrients for production of algae the amounts used are extremely small, with chelated 

micronutrients maintained at levels of microgram moles per litre, parts per billion. Further, such 

use occurs in completely closed systems such as glass flasks, containers, on-shore tanks and 

ponds, and not in open water. For these reasons, the environmental impact of using lignin 

sulfonate in these kinds of systems is expected to be minimal or negligible

105/186
In reviewing whether use of synthetic lignin sulfonate is compatible with organic agriculture the 

subcommittee took into consideration the Organic Foods Production Act (OFPA) which limits 

use of synthetics to various categories one of which is “copper and sulfur compounds” and lignin 

sulfonate is listed by inference as part of that group. 

In determining if the petitioned substance is essential to organic agriculture the subcommittee 

reviewed availability of any natural, non synthetic alternative material given that OFPA states 

that “To be sold or labeled as an organically produced agricultural product under this title, an 

agricultural product shall (1) Have been produced and handled without the use of synthetic 

chemicals except as otherwise provided in this title;.........” (6504 (1)). Nonsynthetic chelating 

agents include citric acid. However citric acid is also a nutrient source for algae and when used 

as a trace mineral chelator it can cause high levels of trace minerals to accumulate in the plant 

tissue. Nonsynthetic amino acids, humates, fulvates and organic root exudates can be used in 

soil environments, but presently it is not known if these soil substances would work in aquatic 

conditions. Therefore there are presently no known alternatives to synthetic lignin sulfonate as a 

chelating agent which would permit adequate nutrient uptake by micro and macro algae in 

aquatic containers.

It should be noted that at the time of drafting this proposal there are no federal standards 

promulgated for aquatic plant or animal production and this proposal is based on NOSB 

Recommendations of standards voted in 2007, 2008 and 2009.

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment x☐ Yes No ☐ N/A 

2. Essential & Availability Criteria x☐ Yes No ☐ N/A

 3. Compatibility & Consistency x☐ Yes No ☐ N/A

Substance Fails Criteria Category: Comments: N/A

Subcommittee Action & Vote

Classification Motion: Move to classify Lignin Sulfonate CAS numbers: 8062-15-5 (lignin 

sulfonic acid), 8061-51-6 (sodium lignosulfonate/ lignin sulfonic acid sodium salt) and 9009-

75-0 (sodium lignosulfonate), as synthetic.

Motion by: C. Reuben Walker 

Seconded by: Mac Stone

Yes: 6 No: 1 Absent: 0 Abstain: 0 Recuse: 0 

Listing Motion: Motion to list Lignin Sulfonate (CAS #s: 8062-15-5 (lignin sulfonic acid), 

8061-51-6 (sodium sulfonate/lignin sulfonic acid sodium salt), and 9009-75-0 (sodium 

lignosulfonate), as chelating agents at §205.609 of the National List 

Motion by: C. Reuben Walker 

Seconded by: Mac Stone

Yes: 6 No: 1 Absent: 0 Abstain: 0 Recuse: 0 

 

Proposed Annotation (if any): none 

106/186
Basis for annotation: ☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Approved by Tracy Favre, Subcommittee Chair, to transmit to NOSB January 21, 2014

NOSB Evaluation Criteria for Substances Added To the National List: Crops

Category 1. Adverse impacts on humans or the environment? Lignin Sulfonate for aquatic 

plants

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse,? 

[§6518(m)(3)]

x Lignin sulfonates are soluble in water with 

potential for decrease in BOD and pH 

(TR 332-226), but with chelated 

micronutrients maintained at levels of 

microgram moles per litre, parts per 

billion, (Petition p. 3) and used in 

completely closed tanks, or containers for 

algae production, environmental damage 

through use or misuse is unlikely.

2. Is there a probability of environmental 

contamination during manufacture or 

disposal? [§6518(m)(3)]

x Lignin sulfonates are bi-products of the

Paper Industry. There are several 

processes used for production of lignin 

sulfonates: sulfite chemical pulping, the 

Kraft process, acid sulfite pulping (TR 

239-258). While there may be adverse 

impacts from high levels of lignin 

sulfonates, normal use indicates no 

evidence of toxicity. (TR 300-330). 

Concerns about presence of dioxins and 

furans in lignin sulfonates produced by 

the Kraft process have largely been put to 

rest, with tests indicating non-detect 

levels (TR 339-348). Large spills of paper 

mill effluent could negatively impact 

nearby waterways and environmentally 

sensitive area (TR 366-368). Production 

of chelated micronutrients may require 

that dump water containing 

lignosulfonates be processed in a 

treatment system. 

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X See 1 and 2 above

107/186
4. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)] 

x Lignin sulfonate is listed by inference as 

part of the group “copper and sulfur 

compounds” in the OFPA Section 6517 

c)1) B) i) and

Lignin sulfonate is a synthetic inert 

ingredient that is not classified by EPA as 

an inert of biological concern. 

And it is exempt from requirement of 

tolerance under 40 CFR parts 180.910 

and 180.930 (TR 227-232)

5. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)]

x

6. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518(m)(2)]

x As noted in 1 and 2 above. Lignin 

sulfonates are water soluble so it is 

possible for dissolved lignosulfonates to 

enter waterways through direct 

contamination or run off from land 

surfaces, and lignosulfonates may be 

toxic to fish (TR 332-337) However, in the 

ppb amounts and enclosed 

containers/tanks to be used no concerns 

are raised in the TR

7. Is there persistence or concentration of 

the material or breakdown products in 

the environment? [§6518(m)(2)]

x As noted in 1 and 2 and 5 above.

Little information is available on 

bioaccumulation of lignosulfonates (TR 

276-278 )

Lignosulfonates break down in soil in 

about a year

8. Would the use of the substance be 

harmful to human health or the 

environment? [§6517 (c)(1)(A)(i); §6517 

(c)(2)(A)(i); §6518(m)(4)]

x There is no research indicating any 

negative human health impacts (TR 491-

496)

Environmental impacts are noted in 1, 2, 

& 8

108/186
9. Are there adverse biological and 

chemical interactions in the agroecosystem, including biodiversity? 

[§6518(m)(5)]

x Lignosulfonates discharged into water 

bodies may cause foaming and 

discoloration (TR 274-276) and may 

contaminate waterways following rain 

events (TR 370-373). Due to their high 

biological oxygen demand (BOD) during 

breakdown in water, lignosulfonates 

increase acidity, lower oxygen and can 

lead to benthic changes, and decreased 

biodiversity unless properly monitored 

and regulated with the goal of increasing 

biodiversity in open systems and can 

corrode aluminum in absence of calcium. 

(TR 452-454). However, chelated 

micronutrients for micro and macro-algal 

production will be used in completely 

closed containers and there should be no 

ecosystem or biodiversity impact

.

10. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518(m)(5)]

x See 6 and 8 above. 

Lignosulfonates used as chelating agents 

in aquatic plant production are used in 

entirely enclosed containers and should 

not run off onto soils.

Category 2. Is the Substance Essential for Organic Production: Lignin Sulfonate for aquatic 

plants

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] x See 3 below

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

x TR 239-258, and Petition p. 5

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

x Lignin sulfonate is a by-product of paper 

pulping and thus has already been 

chemically altered prior to use as a 

chelating agent in production of 

micronutrients for algae production

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

x See 3 above

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

x Lignin occurs naturally in wood, but lignin 

sulfonate does not have a natural source.

6. Is there an organic substitute? 

[§205.600(b)(1)]

x

109/186
7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)] 

x Nonsynthetic amino acids and 

nonsynthetic citric acid are allowed for 

use as chelating agents (TR 544-547)

However, Citric acid is non-functional in 

aquatic environments and could lead to 

micronutrient toxicity due to uptake of 

excess citric acid and attached metals.

Naturally occurring chelates include 

humates, fulvates and organic root 

exudates in soils (TR 585-590), but are 

not available and cannot be used in 

aquatic substrate.

8. Are there any alternative substances? 

[§6518(m)(6)]

x See 7 above

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)]

x None provided in Petition or TR for 

aquatic production. Further, it should be 

noted that micronutrients are essential for 

aquatic plant growth, and can only be 

taken up by plants if chelated.

Category 3. Is the substance compatible with organic production practices? Lignin Sulfonate

for aquatic plants

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

x Lignin sulfonate is presently on the 

National List as chelating agent in plant 

or soil amendments. At present there are 

no federal standards for aquatic plant 

production

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

x As in 1 above and 6 below

3. If used in livestock feed or pet food, is

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

x

4. If used in livestock feed or pet food, is

the primary use as a preservative? 

[§205.600(b)(4)]

x

5. If used in livestock feed or pet food, is

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)]

x

110/186
6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories: 

[§6517(c)(1)(B)(i); 

copper and sulfur compounds

x Lignin sulfonate is listed by inference as 

part of the group “copper and sulfur 

compounds” in the OFPA section 

6517(c)(1)(B)(i) 

toxins derived from bacteria x

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

x

livestock parasiticides and medicines x

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

x

111/186
112/186
National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Vitamins in aquatic plant production (B1, B12, and H)

+

February 18, 2014

Summary of Proposed Action:

 

Synthetic vitamins B1, B12 and H are proposed to be added to the National List at 205.609 for 

use in production of aquatic plants. Section 205.609 of the National List will contain a list of 

synthetic substances for use in the production of aquatic plants.

Healthy plant growth in water and on land depends on the level of nutrients available in plant 

environment. Synthetic vitamins (B1, C and E) are presently on the National List at 205.601(j)(8) 

as plant or soil amendments. Vitamins B1 (Thiamine), Vitamin B12 (Choline), and Vitamin H are 

the only vitamins being petitioned and for use in organic aquatic plant production, and only for 

use in closed systems. 

The manufacture of vitamins can be by chemical processes, fermentation or extraction 

depending on the specific vitamin. Fermentation can be synthetic or non-synthetic. Vitamins 

should not be considered persistent in marine environments. Adverse effects due to persistence 

are more likely to be seen in closed systems.

Synthetic vitamins are not specifically manufactured for use in aquatic plant production. 

However, the vitamins proposed for use in aquatic plants production are produced from the 

same type of processes and manufacturers of vitamins for organic livestock. 

In reviewing whether vitamins are compatible with organic farming the subcommittee took into 

consideration the Organic Food Production Act (OFPA) which limits the use of synthetics to 

various categories, one of which is “pheromones, soaps, horticultural oils, fish emulsions, 

treated seed, vitamins, and minerals.” Vitamins are listed in the OFPA at 6517(c)(1)(B)(i). 

The NOP received the petition for the use of synthetic vitamins in aquatic plants on August 3, 

2012. The Crops subcommittee deemed the petition sufficient on June 16, 2013; no technical 

review (TR) was requested. In October, 2013, the aquatic petitions were transferred to the 

Livestock Subcommittee to be considered as a group. The crops subcommittee did not request 

a TR because vitamins are already allowed at §205.603(d)(3) for livestock feed, and specific 

ones (B1, C, and E) are allowed for crops at §205.601(j)(8).TR references in this Checklist are 

from the TR dated April 29, 2013 requested by the livestock subcommittee for vitamin use in 

production of aquatic animals.

 

The NOSB seeks public input on the essentiality of the use of vitamins in aquatic plant 

production.

It should be noted that at the time of drafting this proposal there are no federal standards 

promulgated for aquatic or animal production and this proposal is based on NOSB 

Recommendations of Standards voted in 2007, 2008, and 2009. 

113/186
Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment x☐ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria x☐ Yes ☐ No ☐ N/A

3. Compatibility & Consistency x☐ Yes ☐ No ☐ N/A 

Substance Fails Criteria Category: [ ] Comments: N/A

Subcommittee Action & Vote. 

Classification Motion: Motion to classify vitamins (B1, B12, and H), as petitioned, as 

synthetic:

Motion by: Jean Richardson 

Seconded by: Colehour Bondera

Yes: 7 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

Listing Motion: Motion to list vitamins (B1, B12 and H) at §205.609 of the National List 

Motion by: C. Reuben Walker 

Seconded by: Jean Richardson

Yes: 6 No: 1 Absent: 0 Abstain: 0 Recuse: 0 

 Proposed Annotation: None proposed

Basis for annotation: ☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Minority Opinion: see end of document

Approved by Tracy Favre, Subcommittee Chair, to transmit to NOSB February 18, 2014

114/186
NOSB Evaluation Criteria for Substances Added To the National List: Crops

Category 1. Adverse impacts on humans or the environment? Vitamins for aquatic plants 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

X Vitamins are dissolved in growing media 

for aquatic plants in very dilute solutions 

ranging from 0.4-0.02 ppm. Media and 

plant cultures are in containers, such as 

on-shore tanks and ponds. The petitioner 

does NOT seek allowance for synthetic 

vitamins for production of aquatic plants 

in public waters. (Petition page 2).

It is unlikely that vitamin use or misuse 

will result in environmental impairment 

due to their short half lives in aquatic 

systems. (TR 972-973 and 807-829).

Large amounts of vitamins released into 

open waters may result in promotion of 

algal blooms and red-tides (TR 986-987) 

and perhaps eutrophication (TR 1075-

1079).

Overall, accidental release of small 

amounts of vitamins into the environment 

is not assumed to pose any significant 

risk (TR 982-983).

2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

X See 1 above.

Industrial production of synthetic vitamins 

includes use of reagents and 

fermentation waste which can have 

negative environmental impacts, but no 

specific examples of such contamination 

are cited in TR (TR 945-987).

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X See 1 above.

4. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

X No (TR 541-548).

5. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems? [§6518(m)(1)] 

X Overall vitamins should not be 

considered persistent in marine 

environments as these compounds 

readily decompose in oxic (oxygen rich) 

environments (TR 827-829).

115/186
6. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518(m)(2)]

X See 5 above and 7 below.

7. Is there persistence or concentration of 

the material or breakdown products in 

the environment? [§6518(m)(2)]

X See 5 above.

The vitamins petitioned , Thiamine, 

Choline and Biotin are water soluble.

The potential for toxicity is generally 

dependent on the vitamin’s solubility 

properties. Water soluble vitamins 

(thiamine, riboflavin, pyridoxine, 

pantothenic acid, niacin, biotin, folic acid, 

choline, inositol, and ascorbic acid) are 

rapidly depleted and these vitamins do 

not bioaccumulate in animal fatty tissue. 

Lipid-soluble vitamins A, D, E, and K 

bioaccumulate in fatty tissue (TR 847- 

876). Literature on bioaccumulation or 

persistence of vitamins in aquatic 

environments is limited. In general lipid 

soluble vitamins are more likely to 

bioaccumulate in fatty tissues (TR 830-

836). 

Adverse effects due to persistence will be 

more severe in closed systems (TR 805-

806).

8. Would the use of the substance be 

harmful to human health or the 

environment? [§6517 (c)(1)(A)(i); §6517 

(c)(2)(A)(i); §6518(m)(4)]

X See 1, 5, and 7 above.

Limited information is available regarding 

potential for environmental or human 

health toxicity at the small levels used 

(TR 1045-1050).

9. Are there adverse biological and 

chemical interactions in the agroecosystem? [§6518(m)(5)] 

X It is unlikely that vitamins used in closed 

containers during aquatic plant 

production would enter a terrestrial agroecosystem.

No studies have been found indicating 

toxic effects of vitamins in soil dwelling 

organisms (TR 1030-1033).

Overloading aquatic ecosystems with 

nutrients could potentially reduce BOD , 

but with good regulations in place 

negative impacts are unlikely from use in 

closed systems as petitioned.

10. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518(m)(5)] 

X See 1, 7, and 9 above.

No studies have been found indicating 

toxic effects of vitamins on soil-dwelling 

organisms (TR 1033).

116/186
NOSB Evaluation Criteria for Substances Added To the National List: Crops

Category 2. Is the Substance Essential for Organic Production?: Vitamins for aquatic plants 

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X There are 3 vitamins petitioned. 

Production methods vary. All three can 

be produced by fermentation, but are 

typically commercially produced by 

chemical processes (TR 553-554).

Fermentation can be considered 

synthetic or non-synthetic (TR 785-786).

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

X X See 2 above.

Extraction from natural sources is widely 

considered inefficient and low yielding 

(TR 574-773).

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X X There are no known natural alternatives 

(Petition page 7)

Vitamin B1 can be produced from many 

plant sources.

Vitamin B7 can be produced from both 

plant and animal sources, including fish 

meal and fish solubles.

Vitamin B 12 can be produced from 

animal and fish by-products.

6. Is there an organic substitute? 

[§205.600(b)(1)]

X None.

7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)] 

X

8. Are there any alternative substances? 

[§6518(m)(6)] 

X X See 5 above .

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)]

X Little information was provided to be able 

to answer this question

117/186
NOSB Evaluation Criteria for Substances Added To the National List: Crops

Category 3. Is the substance compatible with organic production practices? Vitamins for 

aquatic plants

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)] 

X Vitamins B1, C and E are presently on 

the National List at 205.601(j)(8) as plant 

or soil amendments.

Vitamins are listed in the OFPA at 6517 

(c) (1)(B)(i)

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

X See 1 above. 

3. If used in livestock feed or pet food, is

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X

4. If used in livestock feed or pet food, Is 

the primary use as a preservative? 

[§205.600(b)(4)]

X

5. If used in livestock feed or pet food, Is 

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)]

X

6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories:

[§6517(c)(1)(B)(i); 

copper and sulfur compounds

X X Thiamine and biotin are sulfur containing. 

(TR 537-539).

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X

livestock parasiticides and medicines X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X

Minority Opinion - Vitamins In aquatic plant production

February 21, 2014

A minority of the subcommittee suggested that the subcommittee adopt an annotation motion 

for plant vitamins use in aquaculture that set a 5-year expiration date on the listing, with a 

justification explaining that the specific time frame for an expiration date allows the Board to 

118/186
monitor the use of the material, update its scientific and essentiality review, incentivize 

alternatives and continuous improvement, and vote on the continuation of use pending the 

receipt of a petition requesting that use be extended.

Support for the annotation is based on the following justification: Since this petition is being 

considered in the absence of regulations defining acceptable practices in organic aquaculture, 

essentiality in particular cannot be judged at this time. Therefore, the NOSB needs to reconsider 

the approval in five years at the least. Current consideration of the material has raised issues 

relating to health or environmental impacts, especially relating to those in water receiving 

discharges or open water systems; alternatives derived from natural source; and compatibility 

with organic and sustainable agriculture. In particular, although the petitioner has stated that the 

vitamins would be used in closed systems and needed only for growth of starter cultures, there 

is nothing in the proposed listing from the subcommittee to restrict the use to starter cultures in 

closed systems. The review in 5 years provides an opportunity for the Board to reevaluate and 

vote for the continued or modified use of the material under the same standard of review that is 

used to approve the material initially. 

In addition, the minority makes the following comments and additions to the majority checklist, 

which it believes does not provide a full assessment of environmental and health standards 

review required under the Organic Foods Production Act (OFPA): The petitioner has told the 

subcommittee that the vitamins will be used only in closed systems for starting cultures. The 

minority believes that this should be part of the annotation.

With regard to checklist Category 1, Adverse Impacts on Humans and the Environment, the 

minority believes the following need to be considered:

• Vitamin B1: Commercial production involves a six-step synthetic procedure beginning 

with ethyl 3-ethoxypropionate as the feedstock and reactants including ethyl formate, 

acetamidine hydrochloride, phosphorus(V) oxychloride, alcoholic ammonia, hydrobromic 

acid, and 4-methyl 5-hydroxyethyl thiazole. TR lines 594-600.

• A search of the patent literature revealed two methods for vitamin B1 (thiamine) 

production by fermentative methods that appear to use genetically engineered bacteria. 

TR lines 601-606.

• Vitamin B7 (H, biotin): The synthesis begins with fumaric acid as the starting material 

and involves 15 linear synthetic steps, including vicinal bromination of fumaric acid, 

benzylamine, oxalyl chloride, acetic anhydride, zinc, acetic anhydride, acetic acid, 

dihydrogen sulfide, potassium hydrosulfide, zinc/acetic acid, an appropriate Grignard 

reagent, hydrogen over palladium, hydrobromic acid, silver d-camphorsulfonate, sodium 

diethyl malonate, and hydrobromic acid. TR lines 660-672. 

• Microbial fermentation methods have been developed to produce only the biologically 

active isomer of biotin. As an example, a microorganism of the genus Kurthia (bacteria) 

was developed with resistance through exposure to a mutagen, selecting lines capable 

of producing d-biotin under aerobic conditions (Hoshino, 2002). TR lines 673-679.

• MSDSs for several feedstock chemicals and other chemical reagents used in the 

synthesis of biotin (vitamin B7) indicate the potential for ecological damage if 

accidentally released into the environment. TR lines 946-946.

• Vitamin B12. Microorganism fermentation is the exclusive commercial method of 

synthesizing vitamin B12. Some strains are genetically engineered. TR lines 770-773.

• All: The fermentative production of vitamins presents a slight risk of product 

contamination from genetic material in the fermentation broth and any chemicals used 

during processing. TR lines 918-920.

• If released to the water, most of the water-soluble vitamins are not expected to adsorb to 

suspended solids and sediment. TR lines 930-931.

119/186
• Many of the feedstock chemicals and reagents used in vitamin synthetic procedures are 

considered petrochemicals or may be obtained from genetically modified organisms 

(GMOs). Acetone, for example, is a commonly used chemical reagent derived from 

petroleum as well as from GMOs such as corn. TR lines 955-958

• Waste streams resulting from the fermentative production of vitamins may also pose 

risks to the environment. In general, the EPA assumes “no control features for the 

fermentor offgases, and no inactivation of the fermentation broth for the liquid and solid 

waste releases,” suggesting that environmental exposure to these waste streams is 

likely. Some potential risks to the environment include the transfer of novel genes into 

crops, poisoned wildlife, and the creation of new and more potent viruses, in addition to 

a host of unknown risks. TR lines 959-966.

• Release of large amounts of vitamins into the environment may result in eco-toxic 

events, such as the promotion of algal blooms and red tides. TR lines 985-987. 

• Unicellular photosynthetic algae require nutritional intake of vitamin B1 (thiamine), B7 

(biotin), and B12 (cobalamin) (NAS, 1969). These vitamins, as well as other macro- and

micronutrients, can be a limiting growth factor for environmentally beneficial and 

deleterious algae. TR lines 976-979

• Excessive vitamin loadings can lead to synergistic and/or antagonistic effects for the 

absorption and bioavailability of minerals and other trace nutrients. TR lines 1011-1012.

• Overloading aquatic ecosystems with nutrients, such as vitamins, could potentially lead 

to depletion of the dissolved oxygen content and eutrophication. This is commonly 

manifested through occurrences of algal blooms and red tides, fish kills, and overall loss 

of biodiversity from the aquatic system. TR lines 1075-1077.

With regard to checklist Category 2, Essentiality, the minority believes the following need to be 

considered:

• Vitamins B1, B7, and B12 may all be produced through fermentation. Vitamins B1 and 

B7 may also be produced through chemical reactions of synthetic chemicals. (See 

Category 1, question 2.)

• Natural forms are produced by plants, animals, and microorganisms.

• Natural sources of the three vitamins include:

o Vitamin B1: Dried brewers yeast, wheat middlings, wheat mill run, rice bran, rice 

polishings, dried torula yeast, groundnut (peanut) meal, wheat bran, barley, dried 

fish solubles, cottonseed meal, soybean meal, linseed meal, dried distillers 

solubles, broad beans, lima beans, dried delactose whey, glandular meals 

(liver/kidney), green leafy crops, outer coat or germ of cereals. 

o Vitamin B7: Dried brewers yeast, dried torula yeast, dried distillers solubles, 

rapeseed meal, safflower seed meal, sunflower seed meal, whole hens eggs, 

rice polishings, dried brewers grains, liver and lung meal, rice bran, dried 

delactose whey, cottonseed meal, groundnut meal, soybean meal, dried skim 

milk, alfalfa meal, oats, sorghum, dried blood meal, dried fish solubles, fish meal, 

wheat bran, wheat mill run, legumes, green vegetables. 

o Vitamin B12: Animal by-products, liver, kidney, heart, muscle meats, fish meals, 

shellfish, meat and bone meal, condensed fish solubles, and poultry by-product 

meal. TR lines 1189-1192; 1207-1211; 1237-1238.

Under Category 3, Compatibility, the minority points out the following:

• Compatibility depends on how they are used—on routine basis, or occasionally, when 

needed. 

• Synthetic vitamins are permitted for animals only when natural vitamins are not available 

in EEC, UK, Japan, and IFOAM standards. TR lines 495-525.

• It is not sustainable to depend on external synthetic inputs.

120/186
National Organic Standards Board

Compliance, Accreditation, and Certification Sub-Committee

Request for NOP Clarification and Guidance on Retail Compliance and Certification

*Reviewed February 25, 2014 - Minor revisions.

1. Introduction

While the National Organic Standards and various National Organic Program (NOP) guidance 

resources are clear on the compliance expectations for growers, handlers, and livestock 

operators, the NOP’s expectations are less clear for retail operators. Retail stores function not 

only as handlers of organic products, but also as purchasers, verifiers, and marketers of specific 

products and organic agriculture in general. In many cases, retail operations are exempt from 

the requirement for certification for handlers (7 CFR 205.101(a)(2)) and excluded from the 

certification requirement (§205.101(b)(2)). However, exclusion and exemption are not 

completely clear regarding the extent to which a retailer may handle and process products while 

still qualifying for the exemption and/or exclusion. Numerous retailers have become voluntarily 

certified as handlers, yet there are many areas where handling organic system plans (OSP) and 

operational expectations do not apply directly to retail operations, and the retail sector would 

benefit from clearer NOP guidance on its expectations for compliance for certified and noncertified retail operations. Finally, retailers who sell both organic and non-organic products, 

market their certification to consumers, often using the USDA seal. Retailers (along with other 

producers) need clear guidance on the use of the USDA Organic Seal and the “organic” claim in 

general, in the marketing of split operations.

The CAC Subcommittee (CACS) prepared a discussion document on this topic for the 

scheduled 2013 NOSB meeting in Louisville. While that meeting was not held, we received 

sufficient written comments from organic stakeholders to move forward with a proposal. The 

discussion document sought to engage all impacted stakeholders and ask for their input as to 

what specific issues need more clarity to help with understanding and compliance. We also 

sought detailed information about any existing inconsistencies that could use more clarity to

enable a more consistent process of review and accreditation by the various accredited 

certifying agents (ACAs), NOP, and ultimately the retailers themselves. 

Based on public comment received for the fall 2013 meeting, the subcommittee has prepared a 

proposal which asks the National Organic Program to provide enhanced education and 

outreach targeting the retail sector. The intent is to attempt to accomplish this through education 

and outreach, in a way that can provide better clarification to assist the retailers and certifiers 

with a more clear and concise understanding of what is required of an organic retailer by the 

regulation. 

2. Background

In 2009, the NOSB approved a CACS Guidance Recommendation entitled “Clarification of 

Marketing for Voluntary Retail Certification.” This recommendation presented general 

background on the exemptions allowed for retailers, and described a need for clearer guidance 

around the use of the USDA seal and the “organic” claim in the marketing of organic retail 

stores. The recommendation acknowledged that the phrase “Certified Organic Retailer” may be 

challenging to a consumer, and identified a need for clearer guidance around the use of this 

term. 

121/186
The 2009 recommendation then identifies a number of specific certification areas where the 

NOP should provide clearer guidance in order to facilitate consistency and clarity among retail 

operators:

• Guidance on the use of the USDA seal in marketing certified retail operations.

• Clear and consistent guidelines for deli and bakery operations, identifying precisely 

under what conditions certification is required.

• Additional guidance on the ACAs’ role in managing voluntary retail certification 

programs. 

• Clarity on retailers’ role in improving the marketing of voluntary retailer organic 

certification. 

A number of the 2009 NOSB’s recommendations remain unaddressed by the NOP. Given that 

the issues described in the earlier recommendation remain critical, we have updated that 

recommendation to include a number of additional concerns and requests. 

The CAC subcommittee prepared a discussion document for the scheduled fall 2013 NOSB 

meeting, which was cancelled. However, the written public comment received for that 

discussion document was used in the development of the current proposal. 

3. Relevant Areas of the Rule

§ 205.100 What has to be certified.

(a) Except for operations exempt or excluded in § 205.101, each production or handling 

operation or specified portion of a production or handling operation that produces or 

handles crops, livestock, livestock products, or other agricultural products that are 

intended to be sold, labeled, or represented as “100 percent organic,” “organic,” or 

“made with organic (specified ingredients or food group(s))” must be certified according 

to the provisions of subpart E of this part and must meet all other applicable 

requirements of this part.

(b) Any production or handling operation or specified portion of a production or handling 

operation that has been already certified by a certifying agent on the date that the 

certifying agent receives its accreditation under this part shall be deemed to be certified 

under the Act until the operation's next anniversary date of certification. Such recognition 

shall only be available to those operations certified by a certifying agent that receives its 

accreditation within 18 months from February 20, 2001.

(c) Any operation that:

(1) Knowingly sells or labels a product as organic, except in accordance with the 

Act, shall be subject to a civil penalty of not more than 3.91(b)(1)(xxxvii) of this 

title per violation.

(2) Makes a false statement under the Act to the Secretary, a governing State 

official, or an accredited certifying agent shall be subject to the provisions of 

section 1001 of title 18, United States Code.

122/186
§ 205.101 Exemptions and exclusions from certification.

(a) Exemptions. 

(1) A production or handling operation that sells agricultural products as “organic” but 

whose gross agricultural income from organic sales totals $5,000 or less annually is 

exempt from certification under subpart E of this part and from submitting an organic 

system plan for acceptance or approval under § 205.201 but must comply with the 

applicable organic production and handling requirements of subpart C of this part and 

the labeling requirements of § 205.310. The products from such operations shall not be 

used as ingredients identified as organic in processed products produced by another 

handling operation.

(2) A handling operation that is a retail food establishment or portion of a retail food 

establishment that handles organically produced agricultural products but does not 

process them is exempt from the requirements in this part.

(3) A handling operation or portion of a handling operation that only handles agricultural 

products that contain less than 70 percent organic ingredients by total weight of the 

finished product (excluding water and salt) is exempt from the requirements in this part, 

except:

(i) The provisions for prevention of contact of organic products with prohibited 

substances set forth in § 205.272 with respect to any organically produced 

ingredients used in an agricultural product;

(ii) The labeling provisions of §§ 205.305 and 205.310; and

(iii) The recordkeeping provisions in paragraph (c) of this section.

(4) A handling operation or portion of a handling operation that only identifies organic 

ingredients on the information panel is exempt from the requirements in this part, except:

(i) The provisions for prevention of contact of organic products with prohibited 

substances set forth in § 205.272 with respect to any organically produced 

ingredients used in an agricultural product;

(ii) The labeling provisions of §§ 205.305 and 205.310; and

(iii) The recordkeeping provisions in paragraph (c) of this section.

(b) Exclusions. 

(1) A handling operation or portion of a handling operation is excluded from the 

requirements of this part, except for the requirements for the prevention of commingling 

and contact with prohibited substances as set forth in § 205.272 with respect to any 

organically produced products, if such operation or portion of the operation only sells 

organic agricultural products labeled as “100 percent organic,” “organic,” or “made with 

organic (specified ingredients or food group(s))” that:

123/186
(i) Are packaged or otherwise enclosed in a container prior to being received or 

acquired by the operation; and

(ii) Remain in the same package or container and are not otherwise processed 

while in the control of the handling operation.

(2) A handling operation that is a retail food establishment or portion of a retail food 

establishment that processes, on the premises of the retail food establishment, raw and 

ready-to-eat food from agricultural products that were previously labeled as “100 percent 

organic,” “organic,” or “made with organic (specified ingredients or food group(s))” is 

excluded from the requirements in this part, except:

(i) The requirements for the prevention of contact with prohibited substances as 

set forth in § 205.272; and

(ii) The labeling provisions of § 205.310.

(c) Records to be maintained by exempt operations. (1) Any handling operation exempt 

from certification pursuant to paragraph (a)(3) or (a)(4) of this section must maintain 

records sufficient to:

(i) Prove that ingredients identified as organic were organically produced and 

handled; and

(ii) Verify quantities produced from such ingredients.

(2) Records must be maintained for no less than 3 years beyond their creation and the 

operations must allow representatives of the Secretary and the applicable State organic 

programs' governing State official access to these records for inspection and copying 

during normal business hours to determine compliance with the applicable regulations 

set forth in this part.

§ 205.270 Organic handling requirements.

(a) Mechanical or biological methods, including but not limited to cooking, baking, curing, 

heating, drying, mixing, grinding, churning, separating, distilling, extracting, slaughtering, 

cutting, fermenting, eviscerating, preserving, dehydrating, freezing, chilling, or otherwise 

manufacturing, and the packaging, canning, jarring, or otherwise enclosing food in a 

container may be used to process an organically produced agricultural product for the 

purpose of retarding spoilage or otherwise preparing the agricultural product for market.

(b) Nonagricultural substances allowed under § 205.605 and nonorganically produced 

agricultural products allowed under § 205.606 may be used:

(1) In or on a processed agricultural product intended to be sold, labeled, or 

represented as “organic,” pursuant to § 205.301(b), if not commercially available 

in organic form.

124/186
(2) In or on a processed agricultural product intended to be sold, labeled, or 

represented as “made with organic (specified ingredients or food group(s)),” 

pursuant to § 205.301(c).

(c) The handler of an organic handling operation must not use in or on agricultural 

products intended to be sold, labeled, or represented as “100 percent organic,” 

“organic,” or “made with organic (specified ingredients or food group(s)),” or in or on any 

ingredients labeled as organic:

(1) Practices prohibited under paragraphs (e) and (f) of § 205.105.

(2) A volatile synthetic solvent or other synthetic processing aid not allowed 

under § 205.605: Except, that, nonorganic ingredients in products labeled “made 

with organic (specified ingredients or food group(s))” are not subject to this 

requirement.

§ 205.310 Agricultural products produced on an exempt or excluded operation.

(a) An agricultural product organically produced or handled on an exempt or excluded 

operation must not:

(1) Display the USDA seal or any certifying agent's seal or other identifying mark 

which represents the exempt or excluded operation as a certified organic 

operation, or

(2) Be represented as a certified organic product or certified organic ingredient to 

any buyer.

(b) An agricultural product organically produced or handled on an exempt or excluded 

operation may be identified as an organic product or organic ingredient in a 

multiingredient product produced by the exempt or excluded operation. Such product or 

ingredient must not be identified or represented as “organic” in a product processed by 

others.

(c) Such product is subject to requirements specified in paragraph (a) of § 205.300, and 

paragraphs (f)(1) through (f)(7) of § 205.301.

§ 205.311 USDA Seal. 

(a) The USDA seal described in paragraphs (b) and (c) of this section may be used only 

for raw or processed agricultural products described in paragraphs (a), (b), (e)(1), and 

(e)(2) of § 205.301.

(b) The USDA seal must replicate the form and design of the example in figure 1 and 

must be printed legibly and conspicuously:

125/186
(1) On a white background with a brown outer circle and with the term, “USDA,” 

in green overlaying a white upper semicircle and with the term, “organic,” in white 

overlaying the green lower half circle; or

(2) On a white or transparent background with black outer circle and black 

“USDA” on a white or transparent upper half of the circle with a contrasting white 

or transparent “organic” on the black lower half circle.

(3) The green or black lower half circle may have four light lines running from left 

to right and disappearing at the point on the right horizon to resemble a cultivated 

field.

§ 205.400 General requirements for certification.

A person seeking to receive or maintain organic certification under the regulations in this 

part must:

(a) Comply with the Act and applicable organic production and handling regulations of 

this part;

(b) Establish, implement, and update annually an organic production or handling system 

plan that is submitted to an accredited certifying agent as provided for in § 205.200;

(c) Permit on-site inspections with complete access to the production or handling 

operation, including noncertified production and handling areas, structures, and offices 

by the certifying agent as provided for in § 205.403;

(d) Maintain all records applicable to the organic operation for not less than 5 years 

beyond their creation and allow authorized representatives of the Secretary, the 

applicable State organic program's governing State official, and the certifying agent 

access to such records during normal business hours for review and copying to 

determine compliance with the Act and the regulations in this part, as provided for in 

§ 205.104;

(e) Submit the applicable fees charged by the certifying agent; and

(f) Immediately notify the certifying agent concerning any:

126/186
(1) Application, including drift, of a prohibited substance to any field, production 

unit, site, facility, livestock, or product that is part of an operation; and

(2) Change in a certified operation or any portion of a certified operation that may 

affect its compliance with the Act and the regulations in this part.

4. Recommendations

The CACS requests that the NOP provide clear general education and guidance on organic 

compliance to the retail sector, and clarify several specific sections of the Rule as it applies to 

retail operations. 

Education and Outreach

Our discussions and comments received highlighted the need for increased education 

and training for retailers, especially non-certified retailers. While certified retailers receive 

oversight and certification from Accredited Certifying Agents, non-certified retailers 

(including farmers markets and online retailers) do not have the benefit of direct certifier 

outreach. We believe that the NOP can play a more active role in educating retailers 

about the regulatory requirements that govern their operations. Since the implementation 

of the Rule, a number of retailers have become voluntarily certified. As a number of 

commenters noted, such certification can benefit consumers through third-party 

verification of organic sourcing, handling and merchandising activities. NOP educational 

materials for retailers should highlight the opportunity and potential benefits of voluntary 

retail certification. Enhanced education and support services for retailers will ensure 

consistent compliance with the National Organic Standards, increasing consumer 

understanding of and trust in the USDA organic label. 

Clarification of the Rule as it Applies to Retail Operations

Written comments described a number of sections of the regulations which are unclear 

as to how and when they apply to retail stores. We ask the National Organic Program to 

issue concise guidance, in conjunction with the education and training described above, 

which clarifies the application of the Rule’s regulatory requirements to retail operations. 

We support the summary presented by the Organic Trade Association (OTA), based on 

its consultation with its retail members, in its written public comments: 

• Section 205.101(a) and (b) - The requirements for an “exempt” retail 

establishment vs. the requirements for an “excluded” retail establishment are not 

clear.

o Are exempt retailers required to comply with the commingling and 

contamination prevention standard (§ 205.272) and/or the labeling 

provisions (§ 205.310) of the NOP regulations? The regulation under 

exemptions and exclusions (§ 205.101) only specifies that exempt 

retailers maintain records as detailed under § 205.101(c), while excluded 

operations are subject to § 205.272 and § 205.310.

127/186
o Furthermore, are excluded operations required to comply with the record 

requirements of § 205.101(c)? The regulation specifies that records are to 

be maintained by “exempt” operations, but an “excluded” operation is not 

mentioned. In other words, the regulations appear to require the following:

 Exempt retailers are required to maintain records as detailed 

under § 205.101(c).

 Excluded retailers are required to comply with the commingling

and contamination prevention standard and comply with the 

labeling provisions of § 205.310.

o Can an exempt or an excluded retail establishment handle or process 

NOP certified products and then sell the products off-site? For example, 

can the products be handled or processed on-site of the retail 

establishment, but then sold as “organic” at a farmers’ retail sales? The 

regulation is clear that excluded retail establishments must process “on 

the premises of the retail food establishment.” The regulation is not clear 

about “where” the sale of the product must occur.

• Sections 205.308, 205.309 and 205.310 – Labeling requirements:

o Can an exempt non-certified retail establishment “handle” a product and 

then display the USDA seal or represent the product as “certified” 

organic? In other words, can they handle a product (either transfer the 

product from a container to a display case, or, transfer from the product 

from the original container to a store container (i.e., bulk flour bin)) and 

then transfer the information from the original container/label to the store 

display label?

As noted in the discussion document, the exemption in 7 CFR 205.101(a)(2) applies to a 

retailer that “handles but not process” organic agriculture products. However, the 

definition of “handle” in §205.2 includes the term “process,” which is also defined in the 

regulation. While we believe that the intent of the regulation is to exclude retailers who 

handle organic products but do not otherwise transform them, we ask that the NOP 

clarify the precise contours of this exemption, especially as they apply to simple 

repackaging of organic foods. 

We also ask that the NOP clarify the application of the exemption and exclusion to online 

businesses that ship organic products to customers, including the retail portions of 

certified farms and processing facilities that conduct online sales. As noted in the OTA’s 

comments, the regulation clearly requires that processing activities occur on the retail 

premises, but does not specify where the sales of such products must occur. Does the 

online sales activity of a retail business constitute a “retail food establishment,” and if the 

exemption does apply to online retailers, how should such products be labeled?

Finally, the written comments confirm an opportunity for clarification as to the conditions 

under which a retailer may label a product as “certified organic” or use the USDA seal 

when, for example, organic produce is removed from packaging and merchandised, or a 

bulk grain is placed into a bulk bin. The OTA notes:

128/186
There appears to be some contradiction between sections 205.308, 205.309 and 

205.310 of the regulations, all of which together address how products at the 

point of retail can be labeled, and how products produced on exempt and 

excluded operations can be labeled.

As we have explained above, § 205.308 could be read to mean that a product 

produced in a certified facility can be displayed in a retail display using the USDA 

seal and identifying mark of the certifying agent. There is some confusion, 

however, about whether “prepared in a certified facility” would apply to the 

retailer that is handling or processing the product, in which case the retailer 

would need to be certified in order to display the USDA seal or make reference to 

certification. Furthermore, § 205.310 states that an agricultural product produced 

or handled in an excluded or exempt operation must not display the USDA seal 

or represent the product as certified organic.

The current and common practice at non-certified exempt retail establishments is 

to handle certified organic products and transfer from a box to a display case or 

from a bag into a bulk bin the same information as provided on the original 

container. For example, a bag of certified organic flour would be transferred to a 

bulk bin and the bulk bin label would display “certified organic flour. “ It may also 

display the USDA seal. We believe this practice is compliant, as supported by 

section § 205.308 of the regulations. However, clarification is needed.

In conclusion, we ask that the NOP develop clear and actionable guidance for retailers on the 

points noted above and in the earlier discussion document. The development of such guidance 

should include the consultation of retailers and ACAs. We believe that focused education and 

outreach to the retail sector will help improve compliance with the regulation, foster consistency 

across certified and non-certified operations, and promote consumer confidence in the USDA 

Organic label. Retailers represent the final interface with consumers in the organic supply chain, 

and it is crucial that organic integrity in merchandising, handling and marketing be vigilantly 

maintained. 

Recommended Motion:

Motion to accept the Request for NOP Clarification and Guidance on Retail Compliance and 

Certification proposal

Subcommittee Vote: 

Motion by: Jean Richardson

Seconded by: John Foster

Discussion: none

Yes: 7 No: 0 Abstain: 0 Absent: 0 Recuse: 0

Approved by Carmela Beck, Subcommittee Chair, to transmit to NOSB February 22, 2014. 

129/186
130/186
National Organic Standards Board

Compliance, Accreditation, and Certification Subcommittee

Proposal

Toward Clarifying Accredited Certifying Agents’ Application of §205.206(e)

August 20, 2013

Reviewed February 11, 2014. No revisions to content; submitted as a proposal instead of 

a discussion document. 

Introduction:

 Organic crop production has passed its first decade of existence under full implementation of 

the National Organic Program (NOP). While many positive features of this program stand out as 

contributing to a more sustainable, healthy environment as a function of the legislation and 

regulations we as an industry and community operate under, from time to time we identify areas 

for possible improvement. One of the legacy features found in the National Organic Standards 

(NOS) that is a derivative of many organic standards in existence prior to the NOP (e.g. CCOF, 

Oregon Tilth) was a codified preference for softer, less invasive, and less disruptive methods of 

pest control over their harder, more invasive, and more disruptive counterparts. The 

Compliance, Accreditation, and Certification Subcommittee (CACS) supports this preference 

without reservation while recognizing that pest control and management is one of the most 

challenging aspects of organic crop production, and that the very existence of a section on pest 

control in the NOS is a formal recognition of the essentiality of such activities to protect crops 

from the myriad of daunting and potentially devastating pests such as insects, mites and other

invertebrates, weeds, plant pathogens, rodents, deer and other vertebrates.

Regulatory Citations Background:

§ 205.206 Crop pest, weed, and disease management practice standard, provides for the 

following:

(a) The producer must use management practices to prevent crop pests, weeds, and 

 diseases including but not limited to:

(1) Crop rotation and soil and crop nutrient management practices, as provided for in 

 §205.203 and 205.205;

(2) Sanitation measures to remove disease vectors, weed seeds, and habitat for pest 

 organisms; and

(3) Cultural practices that enhance crop health, including selection of plant species and 

 varieties with regard to suitability to site-specific conditions and resistance to 

prevalent 

 pests, weeds, and diseases.

(b) Pest problems may be controlled through mechanical or physical methods including but not 

 limited to:

(1) Augmentation or introduction of predators or parasites of the pest species;

(2) Development of habitat for natural enemies of pests;

(3) Nonsynthetic controls such as lures, traps, and repellents.

(c) Weed problems may be controlled through:

(1) Mulching with fully biodegradable materials;

(2) Mowing;

131/186
(3) Livestock grazing;

(4) Hand weeding and mechanical cultivation;

(5) Flame, heat, or electrical means; or

(6) Plastic or other synthetic mulches: Provided that, they are removed from the field at 

 the end of the growing or harvest season.

(d) Disease problems may be controlled through:

(1) Management practices which suppress the spread of disease organisms; or

(2) Application of nonsynthetic biological, botanical, or mineral inputs.

(e) When the practices provided for in paragraphs (a) through (d) of this section are insufficient 

to prevent or control crop pests, weeds, and diseases, a biological or botanical substance 

or a substance included on the National List of synthetic substances allowed for use in 

organic crop production may be applied to prevent, suppress, or control pests, weeds, or 

diseases: Provided, That, the conditions for using the substance are documented in the 

organic system plan.

Discussion:

The Crops, Accreditation, and Certification Subcommittee has determined that there is 

uncertainty and variability in the understanding and application of the mandates and nuances of 

§ 205.206(e). Additionally there appears to be insufficient understanding in how substances 

reviewed and recommended by the NOSB, added to that National List by the Secretary of 

Agriculture, and allowed as listed on § 205.601 are utilized responsibly in the context of the 

cascading requirements found in § 205.206(e). 

The underlying principle guiding this section of the regulation is that only when other, less 

disruptive, less harmful, less toxic methods, strategies, and tactics have been employed and 

found wanting may synthetic substances found on the National List be used as part of an 

Organic System Plan. It was never the intention of the regulation to allow the application of any 

synthetic crop input unless other, less toxic and persistent means had been tried without 

adequate success. This feature is unique in that it is the only federally-regulated mandate for 

Integrated Pest Management while also being a centerpiece of the crop production standards of 

which the organic community can be proud. 

It is the Subcommittee’s contention that a comprehensive and clear understanding of § 

205.206(e) across all sectors of the organic community and industry is essential in the 

continued fair appraisal of substances on the National List and their alternatives, whether that 

appraisal occurs in the sunset process or in consideration of petitions. Only when the process is 

fair and equitable by which alternatives to pesticides—referenced in § 205.206(a)-(d)--are 

assessed as essential and viable can the essentiality and viability of pesticides--referenced in § 

205.206(e)—be assessed fairly and equitably. 

The Subcommittee also contends that the public is generally unaware of the rigors placed on 

organic operations and organic certifiers by § 205.206(e) and therefore undervalues the efforts 

of each in assuring compliance with the applicable regulation. This lack of awareness can allow 

for undeserved skepticism and second-guessing that impedes effective and efficient 

management of crop pests. Clarity about these rigors would serve the community well in 

allowing organic operations to focus on crop production and compliant activities instead of 

defending those actions. 

132/186
Toward clarifying the collective understanding and unifying collective application of § 

205.206(e), the Subcommittee is seeking comments on this subject and in particular would like 

to ask the following questions of the certification community.

1. What activities or practices do you require of applicants and certified operators in their 

Organic System Plans (OSP) with respect to their compliance with §205.206(e)?

2. What form of verification or records from the operator do you require in support of their 

compliance with § 205.206(e), either during review of the OSP, during the inspection, or upon 

the inspection review? 

3. What information do you require when an operator needs to amend their OSP on short notice 

when pest pressure unpredictably or unexpectedly rises beyond their decision threshold?

4. Other than through records, how do you verify that approved substances are applied only 

when other, less toxic or aggressive means have been tried and found wanting? 

Recommended Motion:

To approve and forward to the NOSB the discussion document “Toward Clarifying Accredited 

Certifying Agents’ Application of § 205.206(e)”.

Subcommittee Vote: 

Motion: John Foster

Second: Joe Dickson

Yes: 7 No: 0 Abstain: 0 Absent: 1 Recuse: 0

Approved by Joe Dickson, Subcommittee Chair, to transmit to NOSB August 20, 2013. 

133/186
134/186
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Ammonium Hydroxide

February 19, 2013

*Revised February 18, 2014 - request for further public comment

Summary of Proposed Action:

Ammonium hydroxide is petitioned to be added to the National List at 205.605 as a boiler water 

additive. The Handling subcommittee proposes not to add Ammonium hydroxide to the National 

List. 

Ammonium hydroxide is a powerful alkali petitioned for use as a boiler additive because it 

neutralizes carbonic acid in condensate to prevent corrosion, reducing pH to 8.5 or 9.0. The 

level of ammonium hydroxide required in steam would depend on the level of carbon dioxide in 

the steam. Ammonium hydroxide is produced by the addition of water to Ammonia. Ammonia is 

produced on a large scale worldwide and one of its largest uses by production volume is as an 

ingredient in conventional fertilizer (prohibited in organic agriculture).

Ammonium hydroxide is a severe irritant which must be handled properly because exposure by 

humans and other mammals during production or use presents a serious toxicological concern. 

It is toxic by all routes, inhalation, dermal and ingestion and the toxicity is well documented. It is 

an air and water pollutant and contributes as a greenhouse gas. It is toxic to fish and other 

aquatic species. Spillage could cause considerable environmental damage.

There are a number of alternative practices which can be used instead of boiler additives. 

These include replacement of steam lines with stainless steel piping, water treatment, physical 

or chemical deaeration, interruption of boiler water treatment prior to organic processing runs, 

bleed runs, dismantling and cleaning systems prior to organic food handling, steam to steam 

heat exchangers, a separate secondary boiler to generate steam for direct food contact 

applications.

The petition requests addition of ammonium hydroxide as a “boiler additive” to neutralize carbon 

dioxide in order to prevent acid attack in steam condensate lines. Where steam is used in or on 

food it is termed “culinary steam” and used in food processing for sanitation or sterilization of 

food contact surfaces, including packaging sterilization. 

REQUEST FOR FURTHER PUBLIC COMMENT

The National List currently includes three volatile synthetic amines as boiler additives, namely 

Cyclohexylamine, Diethylaminoethanol , and Octadecyclamine, listed at 205.605(b) for use only

as boiler additives in packaging sterilization. These three boiler additives will be discussed in 

fall, 2014, as part of Sunset Review (for 2016 materials). Because of Sunset Review for the 

three boiler additives listed above, the NOSB seeks further public comment on essentiality of 

ammonium hydroxide as a boiler additive, including scope of use as culinary steam. 

135/186
Evaluation Criteria (Applicability noted for each category; Documentation attached) 

 Criteria Satisfied?

1. Impact on Humans and Environment ☐ Yes X No N/A 

2. Essential & Availability Criteria ☐ Yes X No N/A

3. Compatibility & Consistency ☐ Yes X No N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes No X N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ 3] Comments: 

Ammonium hydroxide has the potential to cause significant toxic damage to humans, mammals, 

aquatic systems and greenhouse gasses and is not essential or compatible with organic 

agriculture and handling.

Proposed Annotation (if any): None proposed

Basis for annotation: ☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

NA 

Recommended Committee Action & Vote

Classification Motion: 

Motion to classify ammonium hydroxide (CAS # 1336-21-6) as petitioned as synthetic 

Motion by: Jean Richardson 

Seconded by: Tracy Favre 

Yes: 6 No: 0 Absent: 2 Abstain: 0 Recuse: 0 

Listing Motion: 

Motion to list ammonium hydroxide (CAS # 1336-21-6) at § 205.605b 

Motion by: Jean Richardson 

Seconded by: Colehour Bondera

Yes: 0 No: 6 Absent: 2 Abstain: 0 Recuse: 0 

Approved by John Foster, Subcommittee Chair, to transmit to NOSB February 19, 2013

NOSB Evaluation Criteria for Substances Added To the National List

Category1. Adverse impacts on humans or the environment? Ammonium hydroxide 

Question Yes No N/A Comments/Documentation. (TAP; 

petition; regulatory agency; other)

1. Are there adverse effects on the 

environment, or is there a probability of 

environmental contamination during use

or misuse of the substance? 

[§205.600(b)(2), [§6518(m)(3)]

X Toxic to environment if spilled or 

volatized to atmosphere (TAP 2001 and 

petition pages 8, 9, and 10)

2. Are there adverse effects on the 

environment or is there a probability of 

environmental contamination during 

manufacture or disposal of the 

substance? [§6518(m)(3)]

X Worker injury through breathing, 

ingestion or dermal contact and terrestrial 

damage with spills during manufacture. 

(Petition pages 8, 9, 10, and TAP 2001).

136/186
3. Are there any adverse impacts on 

biodiversity? (§205.200)

X Toxic damage will occur through spills in 

terrestrial or aquatic systems, and 

ammonia contributes to greenhouse

gases (Petition pages 8-10) Fish are 

particularly at risk for toxic effects.

4. Does the substance contain inerts

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

X

5. Is there undesirable persistence or 

concentration of the material or 

breakdown products in the environment?

[§6518(m)(2)]

X Yes if spilled, or released into air the gas 

contributes to Greenhouse gases.

6. Are there any harmful effects on human 

health from the main substance or the 

ancillary substances that may be added 

to it? [§6517(c))(1)(A)(i); 6517 

(c)(2)(A)(i); §6518(m)(4), 205.600(b)(3)]

X Yes toxic if inhaled, ingested or dermal 

contact

7. Is the substance, and any ancillary 

substances, GRAS when used according 

to FDA’s good manufacturing practices? 

[§205.600(b)(5)]

X

8. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600

(b)(5)]

X

Category 2. Is the Substance Essential for Organic Production? Ammonium hydroxide 

Question Yes No N/A Comments/Documentation. (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X Ammonium hydroxide is manufactured 

from natural gas which is used to convert 

atmospheric nitrogen to ammonia and 

then water is added to produce the 

hydroxide form (petition page 4 and TAP 

2001).

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

X

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X

137/186
6. Is there an organic substitute? 

[§205.600(b)(1)]

X

7. Is the substance essential for handling of 

organically produced agricultural 

products? [§205.600(b)(6)] 

X Processors can utilize a number of alternative 

practices, such as stainless steel pipelines, 

physical and chemical deaeration, interrupt 

boiler water treatment prior to organic 

processing etc. These alternative practices 

cost time and money. (petition page 11) 

although economic considerations are not 

one of the criteria for suitability of materials 

used in organic production systems (TAP 

2001, page 9)

8. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)]

X

9. Are there any alternative substances? 

[§6518(m)(6)]

X There are 3 boiler additives on the NL

10. Is there another practice (in farming or 

handling) that would make the substance 

unnecessary? [§6518(m)(6)] 

X There are a number of alternative practices 

which can be used (Petition page11) These 

include pre-treating water, replacing steam 

pipelines with stainless steel etc.

11. Have the ancillary substances associated 

with the primary substance been 

reviewed? Describe, along with any 

proposed limitations. 

X

Category 3. Is the substance compatible with organic handling practices? Ammonium

hydroxide

Question Yes No N/A Comments/Documentation. (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)] 

X As a general rule ammonia products are 

not considered compatible with organic 

production or handling (TAP 2001, page 

7, page 9

2. Is the manner of the substance’s use, 

manufacture, and disposal compatible 

with organic handling? [§205.600(b)(2)]

X See 1 above

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

X See 1 above

4. Are the ancillary substances reviewed 

compatible with organic handling [?

X

5. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X

6. Is the primary use as a preservative? 

[§205.600(b)(4)]

X

7. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive 

values lost in processing (except when 

required by law)? [§205.600(b)(4)]

X

138/186
Category 4. Is the commercial supply of an organic agricultural substance fragile or potentially 

unavailable? [§6610, 6518, 6519, §205.2, § 205.105(d), §205.600(c)] Ammonium hydroxide

Question Yes No N/A Comments/Documentation. (TAP; 

petition; regulatory agency; other)

1. Is the comparative description as to why 

the non-organic form of the material 

/substance is necessary for use in 

organic handling provided? 

X

2. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance cannot be obtained 

organically in the appropriate form to 

fulfill an essential function in a system of 

organic handling? 

X

3. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance cannot be obtained 

organically in the appropriate quality to 

fulfill an essential function in a system of 

organic handling? 

X

4. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance cannot be obtained 

organically in the appropriate quantity to 

fulfill an essential function in a system of 

organic handling?

X

5. Does the industry information about 

unavailability include (but is not limited 

to) the following?: 

a. Regions of production (including 

factors such as climate and number 

of regions);

X

b. Number of suppliers and amount 

produced;

X

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

X

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

X

e. Other issues which may present a 

challenge to a consistent supply?

X

139/186
140/186
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Glycerin CAS # 56-81-5 

August 20, 2013

Reviewed January 21, 2014 - No revisions

Summary of Proposed Action:

The petitioner has requested removal of Glycerin from 205.605(b) (synthetic materials for 

handling), stating that there is now sufficient quantity of organically produced glycerin and that 

synthetic glycerin is no longer required. The petitioner believes that the process of microbial 

fermentation that is used to produce organic glycerin is a superior method for the production of 

organic glycerin because it uses only mechanical and biological processes as required in 

§205.270(a) without the use of allowed synthetics listed in §205.605(b). Further, they state “An 

important reason that glycerin produced by hydrolysis of fats and oils should have been 

included at §205.606 is that items listed at §205.606 are subject to the restriction that they can 

be used “only when the product is not commercially available in organic form.” Certified organic 

glycerin is currently available, but there is no “commercial availability” requirement to incentivize 

processors to use it or certifiers to require it. This is why glycerin should be removed from the 

National List in order to encourage organic agricultural production.” 

(http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5101924) 

Because glycerin produced by hydrolysis of fats and oils is currently listed at 205.605(b), the 

NOSB seeks public comment regarding the potential impact to producers and industry should 

glycerin as is presently listed be removed from 205.605(b) of the National List. At present, the 

NOSB has not received a petition to add Glycerin produced by other methods to the National 

List. 

Background

Glycerin is a viscous fluid that has a sweet taste. It is used in a wide variety of products 

including food, cosmetics, medical and industrial applications. As listed at 205.605(b), glycerin 

is formulated from hydrolysis of fats and oils. Per the Technical Review (line 122), there are a 

variety of methods for manufacture of glycerin from hydrolysis of fats and oils: 

Table 2 Processes for producing glycerin by hydrolysis of fats and oils

Lemmens Fryer’s Process Oil or fat is subjected in an autoclave to the conjoint action of heat 

and pressure (about 100 PSI) in the presence of an emulsifying and 

accelerating agent, e.g. zinc oxide or hydroxide (sodium hydroxide 

can be substituted) for about eight hours. The strong solution of 

glycerin formed is withdrawn and replaced by a quantity of hot, 

clean and preferably distilled water equal to about one third to one 

fourth of the weight of the original charge of oil or fat and treatment 

continued for an additional four hours. The dilute glycerin obtained 

from the latter part of the process is drawn off and used for the 

initial treatment of the further charge of oil or fat.

Budde and Robertson’s Process The oils or fats are heated and mechanically agitated with water 

and sulphuric acid gas, under pressure in a closed vessel or 

autoclave. The advantage claimed for the process are that the 

contents of the vessel are free from foreign matter introduced by 

reagents and need no purification; that the liberated glycerin is in 

the form of a pure and concentrated solution; that no permanent 

141/186
emulsion is formed and that the fatty acids are not discolored.

Ittner’s Process Coconut oil is kept in an autoclave in the presence of water at 70 

atmospheres pressure and 225-245oC temperature and split into 

fatty acids and glycerin, both being soluble under these conditions 

in water. The glycerin solution separates in the bottom of the 

autoclave. The aqueous solution contains at the end of the splitting 

process more than 30 percent glycerin.

Continuous High Pressure 

Hydrolysis

In this process a constant flow of fat is maintained flowing upward 

through an autoclave column tower against a downward counterflow of water at a pressure of 600 PSI maintained at temperature of 

480-495o

F. Under these conditions, the fat is almost completely 

miscible in water and the hydrolysis take place in a very short time. 

The liberated fatty acids, washed free of glycerin by the downward 

percolating water, leave the top of the column and pass through a 

flash tank while the liberated glycerin dissolves in the downward 

flow of water and is discharged from the bottom of the tower into 

the sweet-water storage tank.

Additionally, per the petitioner “Saponification of natural fats and oils, a process of hydrolyzing 

the agricultural products fat or oil with water (steam) under pressure (high-pressure splitting) or 

with a solution of sodium carbonate, sodium hydroxide, or potassium hydroxide (traditional 

process) to produce synthetic glycerin and fatty acids. The steam process is described in the 

1995 Technical Advisory Panel Report on glycerin. The alkali process is the traditional process 

used to saponify fats and oils.” Hydrolysis of fats and oils does change the chemical properties 

of the source material, and therefore it is considered a synthetic. 

Per the petition: Four general methods of commercial glycerin production are or have been 

used:

1. Chemical synthesis by hydrogenolysis of carbohydrates (21 CFR 178.3500; 21CFR 

172.866)) or by synthesis from propylene (mentioned in the 1995 Technical Advisory 

Panel report on glycerin). Neither chemical synthetic process has ever been deemed 

worthy of serious consideration for use in organic.

2. Biodiesel production comprises reaction of natural fats and oils – triglycerides – with 

methyl alcohol or ethyl alcohol to produce the methyl or ethyl esters of fatty acids. These 

synthetic fatty acid esters are the diesel fuel. Glycerin is a synthetic waste byproduct of 

this chemical process. The commercialization of the biodiesel process in the past few 

years has created an enormous supply of biodiesel glycerin that has largely displaced 

chemical synthesis from propylene. In fact, the low cost of biodiesel glycerin has resulted 

in commercialization of processes to use it as a raw material to produce epichlorohydrin, 

acrolein, propylene glycol, and other organic chemicals. There are safety concerns with 

biodiesel glycerin, discussed in Section B-11. 

3. Saponification of natural fats and oils, a process of hydrolyzing the agricultural products 

fat or oil with water (steam) under pressure (high-pressure splitting) or with a solution of 

sodium carbonate, sodium hydroxide, or potassium hydroxide (traditional process) to 

produce synthetic glycerin and fatty acids. The steam process is described in the 1995 

Technical Advisory Panel Report on glycerin. The alkali process is the traditional 

process used to saponify fats and oils. The three sources of alkali used in this process 

are included in the National List. Glycerin produced by saponification was recommended 

by the NOSB in 1995 for inclusion on the National List with the annotation “produced by 

hydrolysis of fats and oils.” It is currently included on the National List as a synthetic 

nonagricultural substance at §205.605(b) [and also for livestock used at 

§205.603(a)(12)]. Certified organic glycerin is being produced by saponification of 

organic fats and oils.

142/186
4. Microbial fermentation of carbohydrate substances (analogous to citric acid currently 

included in the National List at §205.605(a)) to produce non-synthetic glycerin. This 

production method is briefly mentioned generically in the 1995 TAP Report and referred 

to in the Merck Index monograph on glycerol (glycerin), which cites a U.S. Patent No. 

3,012,945 issued to Noda in 1961 for yeast fermentation to produce glycerin. Currently, 

microbial fermentation of organic cornstarch by the yeast Candida krusei1 is used 

commercially to produce certified organic glycerin as well as non-synthetic non-organic 

glycerin.

Per the TR: Glycerin can be produced organically by the process of microbial fermentation using 

only mechanical and biological processes as required in §205.270(a) without the use of allowed 

synthetics listed in §205.605(b). In addition, certified organic glycerin can be produced by 

hydrolysis of organic fats and oils using either steam splitting or traditional saponification with a 

catalytic amount of an alkali (sodium carbonate, sodium hydroxide, or potassium hydroxide) on 

the National List. Glycerin, produced organically by fermentation is an agricultural product as 

defined in 7 CFR 205.2, since it is a processed product produced from an agricultural 

commodity, e.g. cornstarch (TR lines 130 – 131). There are currently 21 USDA certified organic 

operations supplying glycerin for organic food or cosmetic products. Specific supplier 

information (TR Table Line: 674).

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment X Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☐ Yes X No ☐ N/A

3. Compatibility & Consistency ☐ Yes X No ☐ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes X No ☐ N/A 

as Organic (only for §205.606)

Substance Fails Criteria Category: [ ] Comments: 

Subcommittee Action & Vote, including classification proposal (state actual motion):

Classification Motion: N/A

Listing Motion: Motion to remove Glycerin produced by hydrolysis of fats and oils, CAS # 

56-81-5 from 205.605(b) of the National List.

Motion by: Tracy Favre 

Seconded by: Harold Austin

Yes: 7 No: 0 Absent: 1 Abstain: 0 Recuse: 0 

 Proposed Annotation (if any): N/A

Basis for annotation: ☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Approved by John Foster, Subcommittee Chair, to transmit to NOSB August 20, 2013

143/186
NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment?Substance: Glycerin

Question Yes No N/A Comments/Documentation. (TAP; 

petition; regulatory agency; other)

1. Are there adverse effects on the 

environment, or is there a probability of 

environmental contamination during use

or misuse of the substance? 

[§205.600(b)(2), [§6518(m)(3)]

X Wide variety of uses for food and industrial 

applications. Long-term history of safe use, 

TAP indicates no incidence of industrial 

poisoning. Glycerin should not come into 

contact with a strong oxidizing agent. 

2. Are there adverse effects on the 

environment or is there a probability of 

environmental contamination during 

manufacture or disposal of the 

substance? [§6518(m)(3)]

X For current listing: Manufactured from 

hydrolysis of fats and/or oils using steam 

splitting. Theoretically possible to have spill 

of oils, but unlikely. 

Fermentation methods: Unlikely

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X However, the petitioner claims that the 

residue from biodiesel production is used in 

the manufacture of glycerin, and one could 

argue that growing corn for biodiesel does 

have an impact on biodiversity.

4. Does the substance contain inerts

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

X

5. Is there undesirable persistence or 

concentration of the material or 

breakdown products in the environment?

[§6518(m)(2)]

X Per Environmental Working Group (EWG), 

there seems to be no persistence in the 

environment. TR indicates it is readily 

biodegradable (line 568). 

6. Are there any harmful effects on human 

health from the main substance or the 

ancillary substances that may be added 

to it? [§6517(c))(1)(A)(i); 6517 

(c)(2)(A)(i); §6518(m)(4), 205.600(b)(3)]

X Glycerin is considered GRAS and has a long 

history of safe use in a wide variety of food, 

cosmetic and medical applications. It is 

metabolized as a carbohydrate in the body.

7. Is the substance, and any ancillary 

substances, GRAS when used according 

to FDA’s good manufacturing practices? 

[§205.600(b)(5)]

X See above comment.

8. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600

(b)(5)] 

X Manufactured from hydrolysis of fats and oils 

using steam splitting and then concentrated 

using distillation. Fermentation methods

include isolation of cornstarch from organic 

corn.

144/186
NOSB Evaluation Criteria for Substances Added To the National List Handling

Category 2. Is the Substance Essential for Organic Production? Substance: Glycerin

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? 

[§6502(1)] 

X X As currently listed it is not considered agricultural. 

However, the petitioner makes the argument that 

it should have originally been listed at 205.606 

since it is manufactured using steam. If so, then it 

should be considered agricultural. The 

fermentation method could be considered 

agricultural since it is manufactured using isolated 

cornstarch from organic corn. 

2. Is the substance formulated or 

manufactured by a chemical 

process? [§6502(21)]

X Per the petition: “Saponification of natural fats and 

oils, a process of hydrolyzing the agricultural 

products fat or oil with water (steam) under 

pressure (high-pressure splitting) or with a 

solution of sodium carbonate, sodium hydroxide, 

or potassium hydroxide (traditional process) to 

produce synthetic glycerin and fatty acids. The 

steam process is described in the 1995 Technical 

Advisory Panel Report on glycerin. The alkali 

process is the traditional process used to saponify 

fats and oils. The three sources of alkali used in 

this process are included in the National List.” 

Hydrolysis of fats and oils does change the 

chemical properties of the source material. 

Fermentation methods: The process for producing 

organic glycerin by microbial fermentation from 

carbohydrate substrates begins with organic corn 

from which cornstarch is isolated. The cornstarch 

is treated with enzymes to hydrolyze the starch 

and liberate glucose. The glucose is then 

fermented with an appropriate microorganism to 

produce glycerin. The glycerin is purified by 

passing through ion-exchange columns to remove 

inorganic elements required for growth of the 

microorganism and through activated charcoal to 

remove color and impurities.

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral sources? 

[§6502(21)]

X Hydrolysis is the opposite of condensation. A 

large molecule is split into smaller sections by 

breaking a bond, adding -H to one section and -

OH to the other.

The products are simpler substances. Since it 

involves the addition of water, this explains why 

it is called hydrolysis, meaning splitting by 

water. 

A-B + H2O --> A-H + B-OH 

(http://www.biotopics.co.uk/as/

condensation_and_hydrolysis.html) 

For fermentation method, see above.

145/186
4. Is the substance created by 

naturally occurring biological 

processes? [§6502(21)]

X The process of hydrolysis is a naturally occurring 

process, but this material is manufacturing using 

high heat and pressure. Incidentally, all (food) 

digestion reactions are examples of hydrolysis, 

and the involvement of water is often not 

appreciated. Generally these reactions are 

controlled by enzymes such as carbohydrases, 

proteases, lipases, nucleases, more specific 

examples of which are fairly well known. 

(http://www.biotopics.co.uk/as/

condensation_and_hydrolysis.html) 

For fermentation, see above.

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X

6. Is there an organic substitute? 

[§205.600(b)(1)]

X Petitioner claims to have a fully organic version 

manufacturing using a fermentation process. See 

petition, (http://www.ams.usda.gov/AMSv1.0/

getfile?dDocName=STELPRDC5101924) 

Per the TR: Glycerin can be produced organically 

by the process of microbial fermentation using 

only mechanical and biological processes as 

required in §205.270(a) without the use of allowed 

synthetics listed in §205.605(b). In addition, 

certified organic glycerin can be produced by 

hydrolysis of organic fats and oils using 

either steam splitting or traditional saponification 

with a catalytic amount of an alkali (sodium 

carbonate, sodium hydroxide, or potassium 

hydroxide) on the National List.

7. Is the substance essential for 

handling of organically produced 

agricultural products? 

[§205.600(b)(6)] 

X Glycerin is used in a wide variety of products 

including food, cosmetics, industrial and medical. 

It is a strong humectant. In organic food products 

it is used to improve texture, increase volume and 

is a major carrier for flavorings and colorings.

8. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)] 

X X Alcohols could be used a carriers for flavorings.

And there are myriad other materials that could 

have a similar functional use in other formulations 

(such as softening and mouth feel in ice creams, 

keeping baked items soft, etc.) but glycerin is 

unique in that it can serve in all these functions.

9. Are there any alternative 

substances? 

[§6518(m)(6)]

X Glycerin manufactured from petroleum products, 

glycerin from saponification of fats and oils and 

fermentation methods.

10. Is there another practice (in farming 

or handling) that would make the 

substance unnecessary? 

[§6518(m)(6)]

X X Given the wide use of glycerin, it is likely that 

there are substitutes for particular uses, but it is 

unlikely that any one material would work in all 

the applications where glycerin is used. 

11. Have the ancillary substances

associated with the primary 

substance been reviewed? 

Describe, along with any proposed 

limitations. 

X

146/186
NOSB Evaluation Criteria for Substances Added To the National List

Handling

Category 3. Is the substance compatible with organic handling practices? Substance: Glycerin

Question Yes No N/A Comments/Documentation. (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

X TR says consistent when used with specific 

food products

2. Is the manner of the substance’s use, 

manufacture, and disposal compatible 

with organic handling? [§205.600(b)(2)] 

X Current version on the National List is 

considered a synthetic, therefore it would not 

be preferred for organic handling. According 

to the petitioner, there is now sufficient 

capacity for organically produced glycerin to 

supply the organic market.

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

X Petition is to remove this substance from 

National List

4. Are the ancillary substances reviewed 

compatible with organic handling?

X

5. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X

6. Is the primary use as a preservative? 

[§205.600(b)(4)]

X One of the uses of glycerin is as a 

preservative but it has many more uses

7. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive 

values lost in processing (except when 

required by law)? [§205.600(b)(4)]

X Glycerin is used as a flavor and/or color 

carrier, and is used to improve textures.

Category 4. Is the commercial supply of an organic agricultural substance fragile or potentially 

unavailable? [§6610, 6518, 6519, §205.2, § 205.105(d), §205.600(c)] Substance: Glycerin

 

Question Yes No N/A Comments/Documentation. (TAP; 

petition; regulatory agency; other)

1. Is the comparative description as to why 

the non-organic form of the material 

/substance is necessary for use in 

organic handling provided? 

X Petition is for removal of synthetic glycerin. 

Petitioner claims there is sufficient quantity of 

organic glycerin available. Per the TR: 

Glycerin can be produced organically by the 

process of microbial fermentation using only 

mechanical and biological processes as 

required in §205.270(a) without the use of 

allowed synthetics listed in §205.605(b). In 

addition, certified organic glycerin can be 

produced by hydrolysis of organic fats and 

oils using either steam splitting or traditional 

saponification with a catalytic amount of an 

alkali (sodium carbonate, sodium hydroxide, 

or potassium hydroxide) on the National List. 

2. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

X See above. Petitioner claims there is 

sufficient organic glycerin available and the 

synthetic non-organic version is no longer 

147/186
/substance cannot be obtained 

organically in the appropriate form to 

fulfill an essential function in a system of 

organic handling? 

necessary.

3. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance cannot be obtained 

organically in the appropriate quality to 

fulfill an essential function in a system of 

organic handling? 

X See petition at: 

http://www.ams.usda.gov/AMSv1.0/

getfile?dDocName=STELPRDC5101924

4. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance cannot be obtained 

organically in the appropriate quantity to 

fulfill an essential function in a system of 

organic handling?

X When synthetic glycerin was recommended 

for inclusion on the National List, there was 

an insufficient supply or organic glycerin. 

According to the petitioner, that is no longer 

the case.

Per the TR: There are currently 21 USDA 

certified organic operations supplying glycerin 

for organic food or cosmetic products.

5. Does the industry information about 

unavailability include (but is not limited 

to) the following?: 

a. Regions of production (including 

factors such as climate and number 

of regions);

X

b. Number of suppliers and amount 

produced;

X There are currently 21 USDA certified organic 

operations supplying glycerin for organic food 

or cosmetic products. Specific supplier 

information (TR Table Line: 674)

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

X

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

X

e.Other issues which may present a 

challenge to a consistent supply?

X

148/186
National Organic Standards Board

Handling Subcommittee

Polyalkylene Glycol Monobutyl Ether (PGME)

Discussion Document

August 20, 2013

Reviewed January 21, 2014 - no revisions

I INTRODUCTION

The purpose of this document is to seek public comment on the proposal that the petition for 

PGME be removed from the NOSB workplan after the Fall 2013 meeting, and that the NOP 

should notify the petitioner that PGME is not eligible for petition to 205.605 (b) because it is not 

used in direct contact with organic products.

II BACKGROUND

On December 27, 2012, the NOP received a petition requesting the addition of PGME to section 

205.605 of the National List as a boiler water additive. Based on information in the petition, the 

NOP determined that the substance was eligible for petition to the National List. This decision 

was made based on the description of PGME as a processing aid that functions as a lubricant 

and surfactant within the pelleting process.

On January 28, 2013, the petition was sent to the NOSB Handling Subcommittee for review. 

The HS requested the development of a third-party technical report, which is posted on the NOP 

website.

The technical report, dated June 7, 2013, indicates that, since PGME is non-volatile, it remains 

in the boiler and does not come into direct contact with processed organic products. 

The Handling Subcommittee prepared the Petitioned Material Checklist which was ready for 

final discussion and vote on August 20, 2013, at which time the Subcommittee determined that 

when used as a boiler additive, PGME is not required to be on the National List because it has 

no contact with organic products.

III RELEVANT AREAS OF THE RULE

§ 205.607 Amending the National List. 

“(a) Any person may petition the National Organic Standard Board for the purpose of 

having a substance evaluated by the Board for recommendation to the Secretary for 

inclusion on or deletion from the National List in accordance with the Act.”

The petition requests addition of PGME to 205.605 – “Non agricultural (nonorganic) substances 

allowed as ingredients in or on processed products labeled as “organic” or “made with organic 

(specified ingredients or food group(s).”

§ 205.600 Evaluation criteria for allowed and prohibited substances, methods, and ingredients. 

“(b) In addition to the criteria set forth in the Act, any synthetic substance used as a 

processing aid or adjuvant will be evaluated against the following criteria:

(1) The substance cannot be produced from a natural source and there are no 

organic substitutes;

(2) The substance's manufacture, use, and disposal do not have adverse effects on 

149/186
the environment and are done in a manner compatible with organic handling;

(3) The nutritional quality of the food is maintained when the substance is used, and 

the substance, itself, or its breakdown products do not have an adverse effect on human 

health as defined by applicable Federal regulations;

(4) The substance's primary use is not as a preservative or to recreate or improve 

flavors, colors, textures, or nutritive value lost during processing, except where the 

replacement of nutrients is required by law;

(5) The substance is listed as generally recognized as safe (GRAS) by Food and 

Drug Administration (FDA) when used in accordance with FDA's good manufacturing 

practices (GMP) and contains no residues of heavy metals or other contaminants in 

excess of tolerances set by FDA; and

(6) The substance is essential for the handling of organically produced agricultural 

products.”

IV DISCUSSION

In reviewing PGME and developing the Materials Checklist the Handling Subcommittee found 

the following:

Polyalkylene Glycol Monobutyl Ether (PGME) polymeric fluid is a boiler steam additive

petitioned for use in feed pellet mills. The petition is specifically for PGME with a minimum 

molecular weight of 1500 in accordance with conditions required by 21CFR Section 173.310.

PGME functions to reduce foaming during production of pelleted livestock feeds and also 

functions as a lubricant. PGME has the unique property of inverse solubility such that it 

dissolves easily in cold water, but at temperatures over 104F (cloud point) it is completely 

insoluble. Thus PGME is not delivered with the steam, but remains in the boiler as a precipitate 

until the boiler cools below cloud point and thus PGME does not contact the feed. 

PGME has very low toxicity, is not considered harmful to the environment or humans, and 

presently has a range of uses approved through the FDA. Canadian, CODEX and Japanese 

standards do not address this additive. EEC standards require that processed feeds shall not 

have been processed with the aid of chemically synthesized solvents. IFOAM requires all 

additives to be declared. This material is regulated by FDA as a secondary direct food additive, 

and is not considered a GRAS substance. 

There are no natural sources of PGME and there are not many natural anti-foam chemicals. 

Natural oils, such as cotton seed, lard, sunflower, safflower, palm oil, carnuba and peat waxes 

can be used, but none of them is as effective and none also provide lubricant properties during 

production. Some of the natural oils are available in organic form, but very little data is available 

on use of these oils.

When used as a boiler additive, the Handling subcommittee finds that PGME is not required to 

be on the National List because it has no direct contact with organic products.

V REQUEST FOR PUBLIC COMMENT 

Based on the new information provided in the technical report, there are now questions about 

whether the original eligibility decision made by the NOP is still accurate. The original eligibility 

decision for this substance, which was based on the information contained in the petition only, 

may no longer be applicable.

150/186
This Discussion Document provides the opportunity for the petitioner to comment on the 

accuracy of the technical description of PGME in the technical report and the opportunity for 

other members of the public to comment on the petition and technical report.

Subcommittee Vote:

Motion: To accept the Polyalkylene Glycol Monobutyl Ether (PGME) discussion document as 

amended August 20, 2013. 

Motion by: Tracy Favre

Seconded by: Harold Austin

Yes: 7 No: 0 Abstain: 0 Recuse: 0 Absent: 1 

Approved by John Foster, Subcommittee Chair, to transmit to NOSB August 20, 2013

151/186
152/186
Sunset 2015 Review List - Request for Public Comment

Handling Substances 

*Reviewed and revised: February 26, 2014 

Introduction

As part of the Sunset Process, the National Organic Program (NOP) announces substances on the 

National List of Allowed and Prohibited Substances (National List) that are coming up for sunset review 

by the National Organic Standard Board (NOSB). The following list announces substances that are on the 

National List for use in organic handling which must be reviewed by the NOSB and renewed by the NOP 

before their sunset dates in 2015. This list provides the substance’s current status on the National List, 

use description, references to past technical reports, past NOSB actions, and regulatory history, as 

applicable. If a new technical report has been requested for a substance, this is noted in this list. To see 

if any new technical report is available, please check for updates under the substance name in the 

Petitioned Substances Database. 

Request for Comments

While the NOSB will not complete its review and any recommendations on these substances until the 

Fall 2014 public meeting, the NOP is requesting that the public provide comments about these 

substances to the NOSB as part of the Spring 2014 public meeting. These comments should be provided 

through www.regulations.gov by April 8, 2014 as explained in the meeting notice published in the 

Federal Register on March 10, 2014. 

The Handling Subcommittee has posed specific questions to solicit public comments regarding two of 

the substances, marsala and sherry (fortified cooking wines), due for sunset review by 2015. These 

questions are included in the listing below. 

It is important for the public to engage in the Sunset Process early. We strongly encourage submission of 

comments on these substances in advance of or at the spring 2014 meeting. Providing your comments 

early is important to: 1) ensure that the NOSB has adequate time and information to develop any 

proposals to remove substances based on this information before its fall 2014 meeting; and, as such 2) 

provide stakeholders adequate opportunity to comment on any proposals to remove substances before 

NOSB votes and makes a recommendation at its fall 2014 meeting. 

These comments are necessary to guide the NOSB’s review of each substance against the criteria in the 

Organic Foods Production Act (7 U.S.C. 6518(m)) and the USDA organic regulations (7 CFR 205.600). The 

current substances on the National List were originally recommended by the NOSB based on evidence 

available to the NOSB at the time of their last review which demonstrated that the substances were 

found to be: (1) not harmful to human health or the environment, (2) necessary because of the 

unavailability of wholly nonsynthetic alternatives, and (3) consistent and compatible with organic 

practices. 

Public comments should focus on providing new information about a substance since its last NOSB 

review. Such information could include research or data that may support a change in the NOSB’s 

determination for a substance. 

153/186
Guidance on Submitting Your Comments

Comments should clearly indicate your position on continuing the allowance of substances on this list 

and explain the reasons for your position. You should include relevant information and data to support 

your position (e.g., scientific, environmental, manufacturing, industry impact information, etc.). 

For Comments That Support Substances Under Review:

If you provide comments in support of an allowance of a substance on the National List, you should 

provide new information demonstrating that the substance is: 

(1) not harmful to human health or the environment;

(2) necessary to the production of the agricultural products because of the unavailability of wholly 

nonsynthetic substitute products; and 

(3) consistent with organic handling. 

For Comments That Do Not Support Substances Under Review: 

If you provide comments that do not support a substance on the National List, you should provide 

reasons why the use of the substance should no longer be allowed in organic production or handling. 

Specifically, comments that support the removal of a substance from the National List should provide 

new information since its last NOSB review to demonstrate that the substance is: 

(1) harmful to human health or the environment; 

(2) unnecessary because of the availability of alternatives; and 

(3) inconsistent with organic handling. 

For Comments Addressing the Availability of Alternatives: 

Comments may present information about the viability of alternatives for a substance under sunset 

review. Viable alternatives include, but are not limited to:

o Alternative management practices that would eliminate the need for the specific 

substance; 

o Other currently exempted substances that are on the National List, which could 

eliminate the need for this specific substance; and

o Other organic or nonorganic agricultural substances. 

Your comments should address whether any alternatives have a function and effect equivalent to or 

better than the allowed substance, and whether you want the substance to be allowed or removed from 

the National List. Assertions about alternative substances, except for those alternatives that already 

appear on the National List, should, if possible, include the name and address of the manufacturer of the 

alternative. Further, your comments should include a copy or the specific source of any supportive 

literature, which could include product or practice descriptions; performance and test data; reference 

standards; names and addresses of producers or handlers who have used the alternative under similar 

conditions and the date of use; and an itemized comparison of the function and effect of the proposed 

alternative(s) with substance under review. The following table can help you describe recommended 

alternatives in place of a current substance that you do not want to be continued.

For Comments on Nonorganic Agricultural Substances at Section 205.606. 

For nonorganic agricultural substances on section 205.606, the NOSB Handling Subcommittee requests 

current industry information regarding availability of and history of unavailability of an organic form of 

the substance in the appropriate form, quality, or quantity of the substance. The NOSB Handling 

Subcommittee would like to know if there is a change in supply of organic forms of the substance or 

demand for the substance (i.e. is an allowance for the nonorganic form still needed), as well as any new 

information about alternative substances that the NOSB did not previously consider. 

154/186
Table 1. Guidance on submitting comments for alternatives to substances on the National List.

If the currently listed 

substance is used in... And is a... Then the recommended alternative should be a (an)... 

Handling Nonsynthetic (nonagricultural) substance

- Agricultural substance; or

- Management practice. 

Handling Synthetic substance

- Another currently listed synthetic substance;

- Nonsynthetic (non-agricultural) substance; or

- Management practice. 

 

Written public comments will be accepted through April 8, 2014 via www.regulations.gov. Comments 

received after that date may not be reviewed by the NOSB before the meeting. 

SUNSET 2015: HANDLING SUBSTANCES

Gellan gum Nonsynthetic 

Use – As a nonagricultural (nonorganic) substance allowed as ingredient in or on processed products.

Listing: Gellan gum (CAS # 71010-52-1) – high acyl form only.

Technical Report: 2006

Petition(s): Gellan gum (2004) 

Past NOSB Actions: NOSB review and recommendation for addition to the National List – 04/22/08

Regulatory Background: Proposed rule (including justification) published 06/03/09 (74 FR 26591), 

Added to National List 12/13/2010 (75 FR 7751). 

Sunset Date: 12/14/2015

Reference: 7 CFR 205.605(a)

Tragacanth gum Nonorganic Agricultural

Use – As nonorganically produced agricultural product allowed as ingredient in or on processed 

products.

Listing: Tragacanth gum (CAS #-9000-65-1).

Technical Report: none

Original Petition: Tragacanth Gum (PDF) (2007)

Past NOSB Actions: NOSB review and recommendation for addition to the National List 5/08

Regulatory Background: Proposed rule (including justification) published 06/03/09 (74 FR 26591), 

Added to National List 12/13/2010 (75 FR 7751).

Sunset Date: 12/14/2015

Reference: 7 CFR 205.606(x)

155/186
Marsala Nonorganic Agricultural

Use – As nonorganically produced agricultural product allowed as ingredient in or on processed 

products.

Listing: Fortified cooking wines. (1) Marsala 

Technical Report: none

Petition(s): Marsala, (2007).

Past NOSB Actions: NOSB review and recommendation for addition to the National List 11/30/07. 

Regulatory Background: Proposed rule (including justification) published 06/03/09 (74 FR 26591), 

Added to National List 12/13/2010 (75 FR 7751). 

Sunset Date: 12/14/2015

Specific Questions from Subcommittee: 

As part of the Sunset review process, the Handling Subcommittee is considering putting forth a proposal

to remove Marsala from 205.606 of the National List at the Fall 2014 public meeting. In anticipation of 

this, the Subcommittee seeks public input based on the following:

1. The Handling Subcommittee requests that the public provide comment regarding the commercial 

demand for marsala in organic products and provide comments on the impact that removing it from 

205.606 would have on organic business and/or organic products.

2. Has industry attempted to locate organic sources of marsala and with what degree of success?

3. Are there other ingredients with suitable flavor profiles that could be used in place of marsala, given 

adequate transition time for ingredient inventory and label depletion?

Reference: 7 CFR 205.606(g)(1)

Sherry Nonorganic Agricultural

Use – As nonorganically produced agricultural product allowed as ingredient in or on processed 

products.

Listing: Fortified cooking wines. (2) Sherry

Technical Report: none

Original Petition: Sherry (2007). 

Past NOSB Actions: NOSB review and recommendation for addition to the National List, 05/08

Regulatory Background: Proposed rule (including justification) published 06/03/09 (74 FR 26591), 

Added to National List 12/13/2010 (75 FR 7751).

Sunset Date: 12/14/2015

Specific Questions from Subcommittee:

As part of the Sunset review process, the Handling Subcommittee is considering putting forth a proposal

to remove Sherry from 205.606 of the National List at the fall 2014 public meeting. In anticipation of 

this, the Subcommittee seeks public input based on the following:

156/186
1. The Handling Subcommittee requests that the public provide comment regarding the commercial 

demand for sherry in organic products and provide comments on the impact that removing it from 

205.606 would have on organic business and/or organic products.

2. Has industry attempted to locate organic sources of sherry and with what degree of success?

3. Are there other ingredients with suitable flavor profiles that could be used in place of sherry, given 

adequate transition time for ingredient inventory and label depletion?

Reference: 7 CFR 205.606(g)(2)

157/186
158/186
National Organic Standards Board

Materials Subcommittee

Proposal: Update of the Petition and Technical Review Process

August 27, 2013

Reviewed December 10, 2013 - No revisions

Introduction

The National Organic Program (NOP) has asked the NOSB for input on revising the procedures 

for petitions and technical review. These procedures are encompassed by a 2007 Federal 

Register notice, 72 FR 2167, and sections of the NOSB Policy and Procedures Manual (PPM) 

appearing on pages 34, 35, 37 and 38 of the current version.

This effort is aimed at making it clearer for petitioners to submit complete petitions and to know 

what to expect in the petition process, for the NOSB to have clear policies for reviewing petitions 

in a consistent way, and for the public to have transparency in how petitions are received, 

evaluated and reviewed.

Subjects covered in this proposal include petitioning to add or remove substances to the National 

List, how such petitions proceed once they are received, and how the NOSB determines which 

substances are on the National List. Also covered is the subject of adding, removing or changing 

and annotation placed on a listed substance.

Used throughout this proposal is the strikethrough for old language to be removed, and an 

underline for new language to be added.

Part 1. Procedures for Submitting National List Petitions

Any person may submit a petition requesting a substance to be reviewed by the NOP and NOSB 

at any time. Each substance to be evaluated for the National List must be submitted in a 

separate petition. Only single substances may be petitioned for evaluation; formulated products 

cannot appear on the National List. When submitting petitions, an official petition contact should 

be designated for all correspondence and the petition should provide specific contact information 

including name, address, phone number, fax number and e-mail address.

To facilitate timely NOP review and NOSB consideration of petitions, petitioners must provide 

concise yet comprehensive responses to the required petition information items described under 

the guideline heading ‘‘Information to be included in a Petition.’’ Upon receipt, the NOP will 

review the petition for completeness of the required petition information. If the required petition 

information is incomplete, the petition will be returned to the petitioner with a request for 

additional information.

Petitions for substance evaluations to add a substance onto, remove a substance from, or 

amend a substance presently on the National List involves a public and open process. 

Confidential Business Information (CBI) is no longer accepted in petitions. Petition information 

not categorized and accepted by USDA, pursuant to 7 CFR 1.27(d), as Confidential Business 

Information (CBI) will be considered available to the public for inspection. Published information 

usually cannot be claimed as confidential. When a petition is considered complete and forwarded 

for NOSB evaluation, except for CBI, the petition will be made available for public inspection. 

Substance petitions that are complete and under evaluation by the NOSB will be posted on the 

NOP Web site at: http://www.ams.usda.gov/nop. Public comments may be submitted to either 

159/186
the NOSB or the NOP for any petitioned substance being evaluated by the NOSB. Comments 

also will be posted on the NOP Web site.

Information To Be Included in a Petition 

The guidelines for required information to be included in a petition are as follows: 

Item A—Please indicate which section or sections the petitioned substance will be 

included on and/or removed from the National List. For petitions to change or add an 

annotation to an already listed substance, please indicate in which category of OFPA 

§6517 (c)(1)(B)(i) the substance is listed.

• Synthetic substances allowed for use in organic crop production, § 205.601. 

• Non-synthetic substances prohibited for use in organic crop production, § 205.602. 

• Synthetic substances allowed for use in organic livestock production, § 205.603. 

• Non-synthetic substances prohibited for use in organic livestock production, § 205.604. 

• Non-agricultural (non-organic) substances allowed in or on processed products labeled 

as ‘‘organic’’ or ‘‘made with organic (specified ingredients),’’ § 205.605. 

• Non-organic agricultural substances allowed in or on processed products labeled as 

‘‘organic,’’ § 205.606. 

Item B—Please provide concise and comprehensive responses in providing all of the following 

information items on the substance being petitioned (petitions to change annotations for an 

already listed substance need only complete #s 1, 2 (contact name), 3, 4, 12 (research backing 

up the change) & 13 (petition justification statement): 

1. The substance’s chemical and/or material common name. 

2. The petitioners name address and telephone number, the manufacturer’s or producer’s 

name, address and telephone number (if different) and other contact information of the 

manufacturer/producer of the substance listed in the petition. 

3. The intended or current use of the substance such as use as a pesticide, animal feed 

additive, processing aid, nonagricultural ingredient, sanitizer or disinfectant. If the substance is 

an agricultural ingredient, the petition must provide a list of the types of product(s) (e.g., cereals, 

salad dressings) for which the substance will be used and a description of the substance’s 

function in the product(s) (e.g., ingredient, flavoring agent, emulsifier, processing aid). 

4. A list of the crop, livestock or handling activities for which the substance will be used. If 

used for crops or livestock, the substance’s rate and method of application must be described. If 

used for handling (including processing), the substance’s mode of action must be described. 

5. The source of the substance and a detailed description of its manufacturing or processing 

procedures from the basic component(s) to the final product. Petitioners with concerns for 

confidential business information may follow the guidelines in the Instructions for Submitting CBI

listed in #13. 

6. For Handling substances provide information about the ancillary substances (such as, but 

not limited to, carriers, emulsifiers or stabilizers) that may be included with the petitioned 

substance, including function, type of substance, and source if known.

7. A summary of any available previous reviews by State or private certification programs or 

other organizations of the petitioned substance. If this information is not available, the petitioner 

should state so in the petition. 

8. Information regarding EPA, FDA, and State regulatory authority registrations, including 

registration numbers. The information provided must confirm that the intended use of the 

substance is permitted under EPA or FDA regulations, as applicable. If this information does not 

exist or is not applicable, the petitioner should state so in the petition. 

9. The Chemical Abstract Service (CAS) number or other product numbers of the substance 

and labels of products that contains the petitioned substance. If the substance does not have an 

assigned product number, the petitioner should state so in the petition. 

10. The substance’s physical properties and chemical mode of action including 

160/186
(a) Chemical interactions with other substances, especially substances used in organic 

production;

(b) toxicity and environmental persistence;

(c) environmental impacts from its use and/ or manufacture;

(d) effects on human health; and,

(e) effects on soil organisms, crops, or livestock. 

11. Safety information about the substance including a Material Safety Data Sheet (MSDS) 

and a substance report from the National Institute of Environmental Health Studies. If this 

information does not exist, the petitioner should state so in the petition. 

12. Research information about the substance which includes comprehensive substance 

research reviews and research bibliographies, including reviews and bibliographies which 

present contrasting positions to those presented by the petitioner in supporting the substance’s 

inclusion on or removal from the National List. For petitions to include substances onto the 

National List for organic handling, this information item should include research concerning why 

the substance should be permitted in the production or handling of an organic product, including 

the availability of organic alternatives. Commercial availability does not depend upon geographic 

location or local market conditions. If research information does not exist for the petitioned 

substance or for the contrasting position, the petitioner should state so in the petition. 

13. A ‘‘Petition Justification Statement’’ which provides justification for any of the following 

actions requested in the petition: 

A. Inclusion of a Synthetic on the National List, §§ 205.601, 205.603, 205.605(b) 

. • Explain why the synthetic substance is necessary for the production or handling of an 

organic product. 

. • Describe any non-synthetic substances, synthetic substances on the National List or 

alternative cultural methods1 that could be used in place of the petitioned synthetic substance. 

. • Describe the beneficial effects to the environment, human health, or farm ecosystem 

from use of the synthetic substance that support its use instead of the use of a non-synthetic 

substance or alternative cultural methods. 

B. Removal of a Synthetic From the National List, §§ 205.601, 205.603, 205.605(b) 

. • Explain why the synthetic substance is no longer necessary or appropriate for the 

production or handling of an organic product, making sure to cover all uses of the listed 

substance. 

. • Describe any non-synthetic substances, synthetic substances on the National List or 

alternative cultural methods that could be used in place of the petitioned synthetic substance, 

and their availability and applicability to all situations where the substance is used. 

C. Inclusion of a Prohibition of a Non-Synthetic, §§ 205.602 and 205.604 

. • Explain why the non-synthetic substance should not be permitted in the production of an 

organic product. 

. • Describe other non-synthetic substances or synthetic substances on the National List or 

alternative cultural methods that could be used in place of the petitioned substance. 

D. Removal of a Prohibited Non-Synthetic From the National List, §§ 205.602 and 

205.604 

. • Explain why the non-synthetic substance should be permitted in the production of an 

organic product. 

1 Cultural methods. Methods used to enhance crop health and prevent weed, pest, or disease problems 

without the use of substances; examples include the selection of appropriate varieties and planting sites; 

proper timing and density of plantings; irrigation; and extending a growing season by manipulating the 

microclimate with green houses, cold frames, or wind breaks.

161/186
. • Describe the beneficial effects to the environment, human health, or farm ecosystem 

from use of the non-synthetic substance that supports its use instead of the use of other 

non-synthetic or synthetic substances on the National List or alternative cultural methods. 

E. Inclusion of a Non-Synthetic, Non-Agricultural Substance Onto the National List, § 

205.605(a) 

. • Explain why the substance is necessary for use in organic handling. 

. • Describe non-synthetic or synthetic substances on the National List or alternative 

cultural methods that could be used in place of the petitioned synthetic substance. 

. • Describe any beneficial effects on the environment, or human health from the use of the 

substance that support its use instead of the use of non-synthetic or synthetic substances on the 

National List or alternative cultural methods. 

F. Removal of a Non-Synthetic, Non-Agricultural Substance From the National List, § 

205.605(a) 

. • Explain why the substance is no longer necessary for use in organic handling. 

. • Describe any non-synthetic or synthetic substances on the National List or alternative 

cultural methods that could be used in place of the petitioned substance, making sure to cover all 

uses. 

G. Inclusion of a Non-Organically Produced Agricultural Substance Onto the National 

List, § 205.606 

. • Provide a comparative description on why the non-organic form of the substance is 

necessary for use in organic handling. 

. • Provide current and historical industry information/research/evidence that explains how 

or why the substance cannot be obtained organically in the appropriate form, appropriate quality, 

and appropriate quantity to fulfill an essential function in a system of organic handling. 

• Describe industry information on substance non-availability of organic sources 

including but not limited to the following guidance regarding commercial availability evaluation 

criteria: (1) Regions of production, including factors such as climate and number of regions; (2) 

Number of suppliers and amount produced; (3) Current and historical supplies related to 

weather events such as hurricanes, floods, and droughts that may temporarily halt production or 

destroy crops or supplies; (4) Trade related issues such as evidence of hoarding, war, trade 

barriers, or civil unrest that may temporarily restrict supplies, and 

(5) Other issues which may present a challenge to a consistent supply. 

H. Removal of a Non-Organically Produced Agricultural Substance From the National 

List, § 205.606 

• Provide a comparative description as to why the non-organic form of the substance is 

not necessary for use in organic handling. 

• Provide current and historical industry information/research/evidence that explains how 

or why the substance can be obtained organically in the appropriate form, appropriate 

quality, and appropriate quantity to fulfill an essential function in a system of organic 

handling. 

• Provide new industry information on substance availability of organic sources including 

but not limited to the following guidance commercial availability evaluation criteria:

(1) Region of production, including factors such as climate and number of regions;

(2) Number of suppliers and amount produced;

(3) Current and historical supplies related to weather events such as hurricanes, floods, 

 or droughts that temporarily halt production or destroy crops or supplies;

(4) Trade related issues such as evidence of hoarding, war, trade barriers, and civil 

 unrest that may temporarily restrict supplies and;

(5) Any other issues which may present a challenge to a consistent supply.

162/186
 

I. Adding, amending, or removing an annotation for a listed substance in all sections 

• Provide evidence that the existing annotation is flawed, unnecessary, or outdated.

• Indicate why an annotation is needed or a change to existing one is needed.

• Explain what revision is needed to the annotation and why, with reference to the review 

 criteria. 

13. A Confidential Business Information Statement which describes the specific required 

information contained in the petition that is considered to be Confidential Business Information 

(CBI) or confidential commercial information and the basis for that determination. Petitioners 

should limit their submission of confidential information to that needed to address the areas for 

which this notice requests information. Final determination regarding whether to afford CBI 

treatment to submitted petitions will be made by USDA pursuant to 7 CFR 1.27(d). Instructions 

for submitting CBI to the National List Petition process are presented in the instructions below: 

.(a) Financial or commercial information the petitioner does not want disclosed for competitive 

reasons may be claimed as CBI. Applicants must submit a written justification to support each 

claim. 

.(b) ‘‘Trade secrets’’ (information relating to the production process, such as formulas, 

processes, quality control tests and data, and research methodology) may be claimed as CBI. 

This information must be (1) commercially valuable, (2) used in the applicant’s business, and (3) 

maintained in secrecy. 

.(c) Each page containing CBI material must have ‘‘CBI Copy’’ marked in the upper right corner 

of the page. In the right margin, mark the CBI information with a bracket and ‘‘CBI.’’ 

.(d) The CBI-deleted copy should be a facsimile of the CBI copy, except for spaces occurring in 

the text where CBI has been deleted. Be sure that the CBI-deleted copy is paginated the same 

as the CBI copy (The CBI-deleted copy of the application should be made from the same copy of 

the application which originally contained CBI). Additional material (transitions, paraphrasing, or 

generic substitutions, etc.) should not be included in the CBI-deleted copy. 

.(e) Each page with CBI-deletions should be marked ‘‘CBI-deleted’’ at the upper right corner of 

the page. In the right margin, mark the place where the CBI material has been deleted with a 

bracket and ‘‘CBI-deleted.’’ 

.(f) If several pages are CBI-deleted, a single page designating the numbers of deleted pages 

may be substituted for blank pages. (For example, ‘‘pages 7 through 10 have been 

CBI-deleted.’’) 

.(g) All published references that appear in the CBI copy should be included in the reference list 

of the CBI-deleted copy. Published information cannot be claimed as confidential. 

(h) Final determination regarding whether to afford CBI treatment to submitted petitions will be 

made by USDA pursuant to 7 CFR 1.27(d). If a determination is made to deny CBI treatment, the 

petitioner will be afforded an opportunity to withdraw the submission.

Part 2. NOSB Policy and Procedures Manual proposed revisions

PPM, pp. 34-35:

MATERIALS REVIEW PROCESS

This section presents the procedures followed by the NOSB to evaluate petitions. First, the NOP 

material review process is presented. Second, a review of the NOSB process for selecting and 

reviewing the work of technical advisory panels is provided followed by a description needed in a 

formal petition. Third, the process for NOSB material review is provided. This section concludes 

by providing a graphical description of the sunset review process.

163/186
Evaluation Procedures for Substances Petitioned for Addition or Removal from the 

National List.

The petition process is open to all, including members of the NOSB. The priority system for 

determining in which order petitions are reviewed will be applied to all petitions (Section VIII). 

These procedures also apply to petitions to add, remove, or change an annotation to an already 

listed substance.

Phase 1: Receipt of Petition and Examination of Petition for Completeness and Eligibility 

During this phase the NOP will: 

• Notify the petitioner via letter and/or electronic mail of receipt of the petition. Determine whether 

the petition is complete 

• Determine whether the petitioned substance is eligible for petition under the Organic Foods 

Production Act and its implementing regulations; document this review using the NOP-OFPA 

checklist. 

• Determine whether the petitioned use is approved under the statutory and regulatory authority 

of the Environmental Protection Agency (EPA); the Food and Drug 

Administration (FDA); or other appropriate federal agency if applicable; 

• Identify and secure any confidential business information (CBI) designated by the petitioner; 

• Notify, as applicable, the petitioner via letter and/or electronic mail of determination of 

completeness and eligibility, and acknowledge the designation of certain information as CBI. 

• Upon determination of completeness and eligibility, the following actions will be taken: 

o Publish the petition on NOP website; and 

o Notify the National Organic Standards Board (NOSB) materials committee chairperson and the

chairperson of the committee that the substance is being petitioned for addition or prohibition 

from the National List (Crops, Livestock, Handling or other pertinent committees). This 

notification will be sent via letter and/or electronic mail and inform the chairs that the petition is 

complete and provide OFPA review and EPA/FDA determination checklist. and request 

identification of any questions the appropriate committee wishes to be specifically addressed in 

the contractor’s report. 

 

P. 35

Phase 2: Determine whether a Third Party Technical Review is Required 

During this phase: 

• The NOSB materials committee, working with other applicable NOSB committee has 60 days to 

submit any questions to the NOP. The questions requested by the committee should include 

items that need specific background information, recommended technical expertise, and be 

based on the OFPA criteria. 

• Per the NOP materials review process, the NOSB should review the petition and using the NOP 

checklists for the material determine the following: 

1) Whether the material is deemed appropriate for consideration on the National List (pending 

criteria). If the answer is no to this question, an explanation is required. 

2) If the answer to question #1 is yes, the NOSB committee assigned for the review (as identified 

by the Materials Committee Chair) must decide whether

a) there is sufficient information in the petition, 

b) the committee can reasonably research any pending technical information, or 

c) there is the need to secure a technical review from a third party expert (see section 

titled Procedures for Handling Technical Reviews) 

164/186
3) If the answer to question #1 is no, the appropriate sub Materials Committee Chair will inform 

the NOP that the petition is incomplete and will include an explanation. If the reviewing 

committee concludes there is a need for a third party technical review, the Materials Committee 

Chair will proceed to make the request to the Program. 

• Notify the petitioner, via letter and/or electronic mail, that the petition is incomplete or ineligible; 

or (proceed to Phase 3: Evaluation by a Third Party Expert)

pp. 37-38

PROCEDURES FOR HANDLING TECHNICAL REVIEWS 

The NOSB’s role involves reviewing specific materials; however, a petition could involve a wide 

range of topics. Although members of the Board represent several areas of the organic 

community and hold advanced degrees in different scientific areas, they might lack the expertise, 

or time, required to address the data needs of a petition. In such cases the Board has the option 

of requesting the assistance of third party experts and expecting from these experts a written 

technical review or report. 

Third party experts can consist of the following: 

1. Employees of the USDA such as AMS Science & Technology, Agriculture Research Service, 

or other federal agencies with appropriate expertise, as needed.

2. Consultants or contractors. 

A subcommittee should follow these steps in deciding the need for third party expert: 

1. Define whether the subcommittee has the expertise needed to address the questions related 

to the petition, mainly: 

a. Impact on the environment 

b. Impact to human health 

c. Sustainability and compatibility with organic principles. 

2. If the subcommittee does not have the expertise or resources (e.g., time), the Subcommittee 

chair should make a request to the Chair of the Materials Committee for a third party expert 

specifying: 

a. The third party expert’s required background and level of expertise 

b. Existence of potential sources of conflict that could result in biased reviews. 

3. When requesting the assistance of a third party expert to evaluate a material, a subcommittee 

must identify the main technical issues needed to be addressed including, but not limited to: 

a. All uses of the petitioned material beyond what the petitioner has requested 

b. All uses of the petitioned material in combination with other material(s) that have been already 

approved on the same section of the National List 

c. Interactions of the petitioned material, not addressed by the petitioner, and that may involve 

materials currently on the same section of the National List. 

d. All possible manufacturing methods for a petitioned material. 

e. Potential effects on public health and biodiversity 

f. Environmental risks and hazards including, but not limited to potential for developing pesticide 

resistance, or long-term effects on sustainability 

g. Ancillary substances that may be used in conjunction with handling materials, such are 

carriers, stabilizers or emulsifiers.

4. If required, The Subcommittee should conduct a final review of the technical report and 

complete an assessment on the quality of work performed by the third party expert. 

165/186
These are basic principles that should be considered when dealing with a third party expert: 

1. A Subcommittee cannot proceed with a recommendation on a material if it is determined that 

there is insufficient limited valid scientific information on that material’s impact on the 

environment, human health and its compatibility with organic principles. 

2. The decision to request third party expert needs to be made independent of the availability of 

funds. If there is a lack of funding to secure third party expert advice, the review of the material 

should be placed on hold. 

3. Although the Board has the final word on the approval or rejection of a petition, the decision to 

request a third party expert is the responsibility of the subcommittee reviewing the material. 

4. The decision to define the expertise needed in the third party expert is the responsibility of the 

subcommittee reviewing the material or issue. 

5. To incorporate a diversity of opinions and to minimize the risk of bias, a subcommittee should 

aim to work with a range of technical experts (individuals, or institutions). 

Once the Technical Reports are submitted to the requesting subcommittee, that committee 

determines if the issues have been addressed sufficiently. If there are remaining questions, the 

subcommittee can go back for further clarification and expansion of the technical report. Once 

the information is deemed sufficient, the report is acceptable for public posting.

Subcommittee Vote

Motion to accept the proposal on Updating the petition and TR process as described above and 

voted on August 27

Motion by: Zea Sonnabend

Seconded by: Tracy Favre 

Yes: 7 No: 0 Abstain: 0 Absent: 0 Recuse: 0

Approved by Zea Sonnabend, Subcommittee Chair, to transmit to NOSB August 27, 2013

166/186
National Organic Standards Board

Materials Subcommittee

Proposal: Confidential Business Information in Petitions

July 23, 2013

Reviewed February 25, 2014 - No revisions

Introduction

In preparation for the Spring 2013 NOSB meeting, the Materials Subcommittee submitted for 

Board review and public input a discussion document “Confidential Business Information in 

Petitions”. That document discussed the procedures currently being used to address 

Confidential Business Information (CBI) as it relates to petitions for materials for inclusion on the 

National List, and the challenges associated with evaluation of petitioned materials without full 

and complete information, some of which could be classified as CBI. The document put forth 

two possible recommendations for modification of the current CBI policy, along with the request 

for feedback from the public. 

Possible Recommendation 1:

CBI is not allowed in petitions. Petitioners must provide complete information about 

manufacturing processes and ingredients so that the NOSB and the public can fully evaluate 

each petitioned material. A modified version of this choice would be to not allow CBI for 

manufacturing processes or ingredients but to allow back up research and references to be 

submitted as CBI to assist the TR development.

Possible Recommendation 2:

CBI be allowed in petitions with the following stakeholder responsibilities:

For the National Organic Program

A. The NOP will allow only information meeting the strict definition of CBI to be deleted 

from petitions considered by the board and posted for public viewing. 

B. The NOP must make it clear to petitioners what happens to the CBI submitted and who 

does and does not have access to it, preferably by revising the Petition Guidelines. It 

should be very clear to petitioners that the NOSB does not see the confidential 

information.

C. The Technical Review contractor will have access to the CBI upon request. The 

contractor may then evaluate the CBI and conduct additional research to verify similar 

information.

D. The TR contractor will indicate that they looked at CBI in the course of their review.

For Petitioners

E. Petitioners are highly urged to provide complete information in their petitions, and keep 

CBI to the absolute minimum.

F. Petitions Guideline B.13 requires a statement of reasons for the CBI. This statement 

needs to be clearly stated, and is part of the public petition that will be seen by the 

NOSB.

167/186
G. Petitions will not be considered unless the rules in the Petitions Guidelines for CBI are 

followed completely.

H. Petitioners need to be aware that petitions containing CBI are rarely approved by the 

NOSB and the board reserves the right to reject such a petition that does not give 

complete manufacturing information. The NOSB may also send back a petition as 

incomplete if there is simply not enough information to make a decision.

For the National Organic Standards Board

I. The Policy and Procedures Manual will be updated to reflect any changes to CBI 

procedures based on this recommendation and the NOP revising the petition guidelines.

J. Petitions that come in with CBI will be looked at in the usual way by the subcommittees 

and any that have withheld too much information to allow the Board to make an informed 

decision may be returned to the petitioner. Others will move forward for a Technical 

Review.

K. If a petition is rejected because of CBI, the petitioner may re-petition and disclose the 

CBI. However, the NOSB will treat this at the lower level of priority with other repetitioned substances.

Summary of Public Comments

Not surprisingly, there were differences of opinion regarding the need for allowances for CBI. 

Generally, public comments expressed the need for sufficient information for the NOSB to make 

determinations regarding the classification of materials – synthetic/non-synthetic and or 

agricultural/non-agricultural, and to determine the impact on human health and the environment. 

The majority of commenters expressed the opinion that a full list of ingredients should be 

disclosed. However, some commenters expressed the need for complete transparency 

regarding the full list of ingredients and manufacturing processes in the petitioned material. 

Others had concerns about protection of manufacturing processes and/or recipes of petitioned 

materials, and the potential for impact to participation in the National Organic Program, should 

CBI not be protected. The proposal for an affidavit process was generally either rejected 

outright or the opinion was expressed that the affidavit process would need more detail before it 

could be determined whether or not it would be effective. 

Feedback pointed out the administrative difficulty in maintaining confidentiality of CBI provided 

to the NOSB and not the public and further stated that the transparency of the petition process 

and the relationship of the NOSB to the public could be adversely affected if such a procedure 

was implemented. 

In order for the NOSB to discharge its responsibility for the proper evaluation of a petitioned 

material, the following information should be provided:

1. A complete list of ingredients included in the petitioned material. The exact recipes or 

formulations are not required; only sufficient information so that the NOSB can evaluate 

the impact on human health and the agro-ecosystem;

2. Sufficient information regarding the manufacturing process to allow for determining the 

classification of that material as either synthetic or non-synthetic and/or agricultural/nonagricultural and sufficient information regarding the manufacturing process to allow for 

an assessment of adverse health and environment effects that may be associated with 

168/186
the product's production. Detailed, proprietary information regarding the manufacturing 

process is not required, except as it relates to the statement above.

Petitioners are encouraged to review the Classification of Materials Draft Guidance (NOP 5033), 

the Synthetic/Non-Synthetic Decision Tree (NOP 5033-1), and the Agricultural/Non-Agricultural 

Decision Tree (NOP 5033-2) for draft guidance on what minimum information is necessary for 

determination of Classification of Petitioned Materials.

Conclusion and Recommendation

The NOSB recognizes the investment and risk associated with development of proprietary 

materials and processes. The board’s intention is not to place petitioners at economic risk 

through information provided as part of a petition process. However, the importance of 

transparency of the petition process, the right of the public to fully know the materials included in

or on certified organic products, and the potential for an untenable administrative burden of 

management of CBI precludes the provision of CBI in materials petitions. 

For this reason, the Materials Subcommittee is recommending a revision to the Material Petition 

process to eliminate the provision for Confidential Business Information. 

Subcommittee Vote

The Materials Subcommittee moves to accept this recommendation and present it for full Board 

discussion at the fall 2013 NOSB meeting. 

Motion by: Tracy Favre

Seconded by: Jay Feldman

Yes: 7 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

Approved by Zea Sonnabend, Subcommittee Chair, to transmit to NOSB August 27, 2013

169/186
170/186
National Organic Standards Board

Materials Subcommittee

Proposal: Research Priorities for 2013 

August 27, 2013 

Reviewed December 10, 2013 - No revisions

Introduction

A Recommendation for a Framework to set Research Priorities was approved at the National 

Organic Standards Board (NOSB) meeting in May 2012. Part of that recommendation was that 

the priorities from the previous year of NOSB deliberations would be presented at each fall 

meeting. Therefore, we have collected suggested research topics from the NOSB 

subcommittees and from suggestions within the public comments and present the top research 

priorities for approval this fall.

After a recommendation is finalized by the NOSB each fall the Chair of the Board will make sure 

it is sent to the primary organic research funders such as NIFA, ARS, NRCS, and private 

foundations and other funders that may be identified. In addition all NOP staff, NOSB members 

and stakeholders can use the list for inspiring appropriate research. 

Background

The reasons for encouraging research into organic production systems are well discussed in the 

previous two Materials Committee papers from fall 2011 and spring 2012. 

The recommendation that was passed recommends that potential topics be prioritized. The 

criteria for prioritization are for those topics that the NOSB believes will have the largest longterm impact on growth and integrity of organic agriculture. These criteria are not presented in 

order of importance, but will be evaluated by the Materials Committee in selecting the top 

research needs. 

Criteria for research topics are:

A. Persistent and chronic (i.e., perennial topics of debate and need)

B. Challenging

C. Controversial (i.e., topics on which there are widely differing perspectives or for which 

 there have been close NOSB votes)

D. Nebulous (i.e., the research need is hard to identify but the organic agriculture need is 

 clear), for example, improved methods of weed control.

E. Lacking in primary research. That is, topics for which there is no active research 

 being conducted, primarily relating to the criteria in OFPA for review of materials.

F. Relevant to assessing the need for alternative cultural, biological, and mechanical 

 methods to materials on the National List.

Call for Researchers

We hope that this information will be useful for researchers in many fields to defend and solicit 

funds for research that benefits organic production and handling. Therefore, we invite the public

to comment on these topics, to circulate this widely, and to recommend that funders also 

prioritize these topics. Please submit comments on funders who might want to remain informed 

of research opportunities in organics.

NOSB Research Priorities 2013: 

For 2013 the Subcommittee has re-emphasized four topics that were on the list last year, and 

has added several more pertinent topics. The top priorities are in this section without any 

ranking, with a description of some research questions and why each topic is important. The 

171/186
following section titled "Topics for future review" contains other subjects that the NOSB 

subcommittees put forward but are secondary to the top priorities here. Research into these and 

interrelated issues is urgently needed.

Whole Farm Systems

How can working with the natural world by including diversity of habitat, cropping systems, and 

biological life benefit an organic farm? Selected subjects within this heading include: Can crop 

species and varieties be specifically adapted to their site through plant breeding or cultural 

practices? How does biodiversity contribute to pest and disease resistance? What is the 

relationship between nutrient balancing fertilization practices and microbial life in the soil and 

susceptibility or resistance to pests? How can the need for a diverse ecological system be 

balanced with food safety concerns for a sustainable organic farming system? 

Alternatives to Antibiotics (Tetracycline and Streptomycin) for Fire Blight

With oxytetracycline and streptomycin due to expire from the National List in October of 2014, 

the organic apple and pear growers must find suitable alternatives to control the deadly fire 

blight disease. Since apples and pears are grown throughout the United States in many regions, 

these alternatives must work in a variety of climates and a variety of management systems. The 

following research issues are important to investigate: location, planting density, choice of 

varieties of cultivar and rootstock, soil improvement practices, pruning practices and general 

sanitation, groundcovers or intercrops, pollinator management, dormant copper sprays, bloom 

thinning/lime sulfur, early, full bloom, and late sprays with approved organic materials to prevent 

fire blight establishment, surveys for fire blight activity, and other cultural and preventative 

techniques.

Evaluation of Genetically Modified Vaccines (GMO)

Prevention and avoidance of unintended GMO contamination are foundational to organic 

production and brand. It is of such importance that NOSB has a GMO Ad-Hoc Subcommittee. A 

need exists for research and/or outreach on easier ways to determine the types of vaccines. A 

better way of identifying the types of vaccines is critically important to our stakeholders, 

especially livestock producers. The testing of products that could be alternatives to GMO 

vaccines in livestock production is a top priority.

Methionine Alternative

Methionine is an essential amino acid for poultry. Prior to the 1950’s poultry and pigs were fed a 

plant and meat based diet without synthetic amino acids such as methionine. One former NOSB 

member stated, in §205.237(5) (b), “We have seemingly made vegetarians out of poultry and 

pigs”. As the organic community moves toward reducing, removing, or providing additional 

annotations to synthetic methionine in the diets of poultry, a heighten need exists for the organic 

community to rally around omnivore producers to assist in marshaling our collective efforts in 

finding viable alternatives to synthetic methionine and help find approaches for making them 

more commercially available.

The key research areas are on alternatives such as herbal methionine, corn gluten meal, potato 

meal, management practices, pastures management, fish meals, animal by-products, and other 

non-plant materials. Additional research on the more promising alternatives related to bringing 

them into commercial production is also encouraged.

172/186
Organic Aquaculture

Organically-labeled aquaculture products are increasing rapidly in markets around the world. 

In the U.S., debate continues on appropriate use(s) of the organic label for aquaculture 

systems, and whether such use should be approved for open-water systems as well as closed

systems such as ponds or tanks. Therefore, research efforts pertaining to both open and closed 

systems are needed. 

Research needed includes: 

- evaluating the environmental impacts of fish wastes from aquaculture systems on the 

 environment; 

- appropriateness of feed and other supplements such as trace minerals that may have 

 synthetic sources; 

- organic practices for fish health and management of diseases and parasites; 

- and impacts and control of fish escapes in open water situations.

The subcommittee notes that application of organic agriculture principles (as described in 

OFPA) to aquaculture poses some definitional problems. OFPA refers to organic management 

principles and practices that were developed in the context of terrestrial plant and animal 

systems. Research approaches are needed which explore the extension of these principles to 

aquatic systems. (For example, see following discussion of “aquatic biodiversity”)

Aquatic Biodiversity

Organic farmers promote biodiversity in cultivated and uncultivated areas through crop rotations 

and other practices. They are expected to maintain areas like hedgerows, woodlands, 

wetlands, and wildlife corridors to promote non-crop biodiversity on the farm. The conservation 

of biodiversity must be included in organic systems plans for aquaculture as well. NOSB 

materials recommendations need to be made with a goal of preserving and enhancing 

biodiversity. With the impending implementation of rules on organic aquaculture, it is important 

that decisions be made with a firm understanding of aquatic ecology and possible impacts of the 

Board’s decisions. Decisions concerning terrestrial inputs derived from aquatic environments 

also need to be based on an understanding of the impacts from such activities. 

In particular, the NOSB needs to understand: nutrient and mineral cycling in various aquatic 

systems, the structure of aquatic food webs, the movement of pollutants in various aquatic 

systems, bioaccumulation and bioconcentration in aquatic organisms, and the status and 

impacts of overharvesting and other stresses on aquatic/marine plants and animals. Board 

members, certifiers, and aquaculture operators all need to know how biodiversity conservation 

measures should be implemented in aquaculture systems and materials decisions.

Herd Health

The assessment of preventive organic practices to improve organic livestock health is critical 

and of high importance. These include general animal health as it relates to diseases prevention, 

uterine infections in peri-parturient animals, growth, and identification of vaccine types, nutrition, 

and production systems. Research that could lead practitioners to better prevention strategies, 

use of non-synthetic substances such as feed supplements that would improve health and 

management practices that minimize health issues are all important topics.

Pastured Poultry and Salmonella 

Raising poultry on pasture where the birds get a varied diet, are outdoors and have space to 

roam makes sense from an organic standpoint. But does pasturing of poultry lead to higher 

173/186
rates of Salmonella infection? Some critics have claimed this but there is scant evidence to 

support or refute this opinion. Exploring where Salmonella infections can originate, whether the 

pasture system has some inherent buffering capacity against pathogens getting a foothold, and 

whether there truly is more risk involved in raising organic poultry on pasture are key research 

topics.

Commercial Availability Assessments 

The NOSB must make assessments of commercial availability or organic sources every time 

there is a petition or a sunset review for substances on §205.606 in particular (agricultural 

substances that may be used from non-organic sources). What are some resources for 

commercial availability information? Is it out there? If there is no information available, how 

could such information be developed?

Consumer Demand 

The NOSB get told often by commenters who are or claim to represent consumers that 

consumers have expectations about what organic means and what inputs and ingredients 

should be in organic food. Sometimes there is a wide difference between what consumer 

activist groups claim and sales of specific categories of organic products in the marketplace. 

How can the NOSB determine whether the consumers and groups who speak up are truly 

representing all consumers of organic, and if not, is there a better measure of consumer 

preference and expectations than sales figures for organic products? This has come up in the 

past year with particular regard to fortification by synthetic nutrients in infant formula and other 

processed food, as well as in the apple and pear marketplace with the discussion of 

oxytetracycline. Research into the relationship of consumer buying habits and their beliefs about 

them would be helpful.

Fate of Genetically Engineered Plant Material in Compost? 

What happens to transgenic DNA in the composting process? Materials such as cornstalks from 

GMO corn or manure from cows receiving rBGH are often composted yet there is little 

information on whether the genetically engineered material and traits break down in composting 

process. Do these materials affect the microbial ecology of a compost pile? Is there trait 

expression of Bt (bacillus thuringienses) after composting?

Reduction of Genetically Modified Content of Breeding Lines 

In grappling with the issue of a Seed Purity Standard, it came up in comment that breeding lines 

of corn and other crops had become polluted by GMO pollen entering their germplasm. This 

research question is posed to determine what techniques can be applied to reduce or eliminate

contamination by unintended GMO presence in seed breeding materials. Can lines be "purified" 

so that there are non-detectable levels of GMOs after several selection cycles and how many 

generations would it take?

Topics for Future Review 

This group of topics was submitted by the Crops and Livestock Subcommittees of the NOSB but 

did not make it into the Priorities for Research in 2013. They will remain in consideration for 

future year priorities.

174/186
• Chlorine Alternatives

Chlorine compounds are the most common equipment and food contact sanitizers used in the 

food processing and handling. They are also common disinfecting agents for farm equipment 

and tools. In its reactive forms –chlorine gas, hypochlorite, etc. – chlorine may react with organic 

matter to form organochlorines, which are generally persistent, toxic, carcinogenic, and often 

endocrine disruptors. Sometimes the reactions are purposeful, to create pesticides, solvents, 

pharmaceuticals, and other synthetic chemical products. Other times unintentional byproducts, 

such as chloroform or carbon tetrachloride, result from processes such as disinfection.

The fact that use of chlorine –as opposed to chloride– is so universally associated with the 

production of persistent toxic chemicals has led some environmental groups to seek a ban on 

chlorine-based chemicals. Since chlorine compounds have so many adverse impacts in the 

production-to-disposal life of the materials, we recommend that the NOSB support research to 

determine how organic production can move beyond reliance on chlorine-based materials. 

• Sulfuric Acid Alternatives

Sulfuric acid is commonly used to lower the pH in the manufacture or processing of some 

agricultural inputs. The NOSB has received petitions for sulfuric acid itself and also for materials 

that have sulfuric acid as a processing aid in the manufacture. Recent examples include 

vinasse, magnesium oxide, and laminarin.

In 2006, the Crops Subcommittee voted unanimously to reject a petition to allow use of sulfuric 

acid in anaerobically digested livestock manure because “Sulfuric acid, when used in livestock 

manure, is changed to sulfate, which is in this case a synthetically derived plant nutrient. 

Additionally, it is an important air pollutant, e.g. acid rain. Other wholly natural materials can be 

used.” In 2012, the Crops Subcommittee took a similar position on a similar petition.

Unfortunately, the NOSB is not always able to identify alternatives, despite concerns about 

sulfate as a synthetic plant nutrient and environmental impacts. Research into natural acids or 

other substitutes that could be used in place of sulfuric acid to lower pH in the production of

inputs for organic agriculture, as well as whether the pH lowering step is always required to 

purify, extract or stabilize raw inputs is important to the NOSB deliberations on materials.

• Parasitism

The control of internal and external parasites is important to animal welfare, growth, 

reproduction, and production. In organic production, the control of parasites is critical. The use 

of antibiotics is prohibited. A limited number of substances are available to control parasites. 

Antibiotics are not allowed in organic livestock production for growth, reproduction, and 

production. Antibiotics can be used on sick animals. However, these animals cannot be sold as 

organic. A critical need exists to explore ways to find materials for the control of internal and 

external parasites in organic livestock operations.

• Mastitis

Mastitis is a disease of the mammary gland. It is an inflammation in the mammary gland. It is 

generally associated with dairy cattle. It can be caused by bacteria, physical injury, etc. Mastitis 

is one of the most common and expensive diseases of dairy cattle. It can result in reduced milk 

production, discarded milk, treatment, and veterinary expenses. An urgent need exists for 

looking at ways to reduce mastitis in dairy herds. The research needs include the areas of 

herbal treatment of mastitis and management practices.

• Pneumonia

Pneumonia denotes a swelling of the lungs. Pneumonia is rare when animal populations and 

densities are low. In the winter, animals are housed or gather more closely together, increasing 

175/186
the concentration of pathogens in their environment. Confinement and higher animal densities 

result in increased air temperatures, humidity, and condensation, which are beneficial conditions 

for pathogen survival and transmission. Pneumonia in a herd or flock means animals are not 

performing up to their maximum potential, production costs are higher, labor is increased, and 

food product quality is compromised. Responsible animal caretakers know it is their duty and 

responsibility to address animal welfare concerns and ensure a safe and healthy environment 

for their animals.

Subcommittee Vote

Motion to adopt the proposed recommendation on NOSB Research Priorities for 2013. 

Motion by: Zea Sonnabend

Seconded by: Tracy Favre

Yes: 5 No: 0 Absent: 2 Abstain: 0 Recuse: 0

Approved by Zea Sonnabend, Subcommittee Chair, to transmit to NOSB September 3, 

2013

176/186
National Organic Standards Board

Materials/GMO ad hoc Subcommittee

Report

Seed Purity from GMOs

+

February 25, 2014 

Introduction

The GMO ad hoc Subcommittee has issued a discussion document on Seed Purity from GMOs 

over a period of two NOSB meetings that were six months apart. This report summarizes the 

public comment received from this effort and provides the subcommittee analysis of the 

situation. The subcommittee has chosen not to submit a proposal at this time.

Organic stakeholders are concerned about keeping genetically modified organisms (GMOs) 

(i.e., the products of transgenic plant or animal breeding) out of organic livestock feed, crops, 

and food. The production and handling of organic goods prohibits the use of “excluded 

methods” including transgenic modification. This prohibition applies to seeds used on organic 

farms. The organic community continues to be proactive in developing positions, procedures, 

and practices to prevent GMO contamination. An important part of such prevention is ensuring 

genetic purity of seed used on organic farms. Pure seed is a cornerstone of true sustainability in 

an organic farming system. 

Policy Memo 11-13 from the National Organic Program (NOP) affirms that organic certification 

is process based. Part of that process is implementing measures to prevent and exclude GMOs. 

In order to determine that these preventative practices are adequate to avoid contamination with 

prohibited substances or excluded methods, there may be a role for seed purity testing, similar 

to the role for residue testing.

In the Discussion Document the suggested standard would be based on presence or absence 

of GE content in a specified seed sample size (e.g. 3000 seeds). The use of terms like “nondetect” or ”none found in the sample” is less confusing than the statistical expression 

summarizing what “none found” in a sample means relative to the level of certainty that the 

whole lot is not contaminated.

The public comments to National Organic Standards Board (NOSB) and NOP continue to 

indicate a strong concern by both producers and consumers of organic foods for stronger steps 

to limit the potential and/or unintended presence of GMOs. Seed may be the most impactful and 

efficient point in the supply chain at which GMO contamination of organic feed, crops, and food 

could be limited and controlled. 

The conclusion of the GMO ad hoc Subcommittee is that a seed purity standard can be 

consistent with a process-based standard when analytical limits1 are used to verify that 

adequate measures are in place to prevent contamination with excluded methods. This would 

also be consistent with the residue testing program under NOP.

The challenges of doing this and the valid issues raised by the public are examined here.

1 Using analytical limits means that the sample size is specified in which no contamination is found, as opposed to 

stating a percentage of contaminated seed. The "analytical limit" approach is appropriate for two reasons: (1) No 

contamination is acceptable to the organic community, and (2) the only way to specify a zero contamination level is 

statistically, through specifying the sample size in which no contamination is found.

177/186
Background

• The NOP Organic Rule refers to Genetic Engineering (GE) as an "excluded method". 

“Organic” is a label that indicates that a process has been followed to exclude GMOs. 

• Producing organic feed, crops, and food uncontaminated by GMOs requires starting with seed 

that is not contaminated by GMOs. 

• Public and marketplace expectations for the absence of GMOs in organic goods call for 

implementing best practices on conventional and organic farms to minimize the potential for 

such contamination. 

• We suggest that the process for ensuring genetic purity of commercial seeds in organic 

production must be stricter than conventional crop production. Clean seed must be planted for 

the farmer to harvest uncontaminated food or feed. Planting and harvesting contaminated seed 

can increase the likelihood of “creeping contamination” from year to year, since any additional 

GE contamination in seed handling or pollen drift into a field planted with partially contaminated 

seed would produce food, crops, or feed with a higher level of contamination than in the original 

seed. 

• This strict process must protect organic seed growers in order to protect seed purity. 

• In spite of conventional agriculture's discomfort with the reference to "contamination" from 

genetically altered DNA in organics (such as on page 4 of the public comment from the 

American Seed Trade Association from Sept. 20122

), the entire organic community considers 

GMO movement outside of the areas that they are grown in to be pollution. Therefore the 

encroachment into organic seed and crops is considered to be contamination of organic crops, 

and that is the vernacular used in this report. 

• For the past two years since Genetic Engineering has been addressed in discussion by the 

NOSB, we have received many3 public comments from consumers and farmers alike that 

organic means no GMOs, and maximum effort must be taken to keep them out of organic food.

• The public comment process on the Discussion Document raised several fundamental

concerns about adopting a Seed Purity Standard. These are discussed below. The 

subcommittee analysis and discussion around these concerns is addressed in separate 

sections. 

Relevant areas in the Rule

2 Andrew LaVigne, commenting on behalf of the American Seed Trade Association (ASTA) to Docket AMS-NOP12-0040, Sept. 2012.

3 Ninety-three comments pertaining to the April 2011 NOSB meeting on the Regulations.gov website 

mentioned GE, despite the fact that nothing on the agenda addressed genetically modified organisms. In 

addition, eight people used at least part of their precious three minutes of comment time to address GE. 

The comments came from a variety of viewpoints and reflected a wide range of concerns.

Fourteen comments were received on seed purity discussion paper in October 2012. 

Sixteen commenters submitted comments on the seed purity discussion paper in April 2013. Ten of these 

were commenters who did not submit comments in October 2012. In addition to comments specifically 

addressing agenda issues, 85 comments expressed general concern about GE contamination of organic 

crops and products. 216 comments were received in the Fall of 2013, when no agenda item addressed 

GE.

The largest outpouring of public comments was close to 300,000 comments opposed to GMOs (along 

with irradiation and sewage sludge) in organic production in the original proposed rule in 1998. 

178/186
NOP standards4 adopted by USDA in a final rule published in December 2000 and fully 

implemented in October 2002 prohibited the use of GMOs in the production and handling of 

organic products certified to national organic standards. 

The terminology used for GMOs in the NOP Regulation is “excluded methods” and is specified 

under section 205.2 (Terms Defined) as: 

Excluded methods. A variety of methods used to genetically modify organisms or influence 

their growth and development by means that are not possible under natural conditions or 

processes and are not considered compatible with organic production. Such methods 

include cell fusion, microencapsulation and macroencapsulation, and recombinant DNA 

technology (including gene deletion, gene doubling, introducing a foreign gene, and 

changing the positions of genes when achieved by recombinant DNA technology). Excluded 

methods do not include the use of traditional breeding, conjugation, fermentation, 

hybridization, in vitro fertilization, or tissue culture. 

Detection and Testing Requirements: Under the residue testing requirements of NOP, 

products from certified organic operations may require testing when there is reason to 

believe that certified products have come into contact with prohibited substances or have 

been produced using excluded methods. 

This requirement is specified in Subpart G (Administrative) of the regulations: 

§ 205.670 Inspection and testing of agricultural product to be sold or labeled “organic.” 

(b) The Administrator, applicable State organic program's governing State official, or the 

certifying agent may require pre-harvest or post-harvest testing of any agricultural input used or 

agricultural product to be sold, labeled, or represented as “100 percent organic,” “organic,” or 

“made with organic (specified ingredients or food group(s))” when there is reason to believe that 

the agricultural input or product has come into contact with a prohibited substance or has been 

produced using excluded methods. Such tests must be conducted by the applicable State 

organic program's governing State official or the certifying agent at the official's or certifying 

agent's own expense. 

NOP Policy: The NOP finalized a Policy Memo on July 22, 2011 (Policy Memo 11-13) on GMO. 

This policy memo reiterates that the use of GMOs is prohibited under NOP regulations, and 

answers questions that have been raised concerning GMOs, organic production, and handling. 

The clarification provided is consistent with the explanations provided in the preamble, thus 

emphasizing that organic certification is a process-based standard and the presence of 

detectable GMO presence alone does not necessarily constitute a violation of the regulation. 

Commercial Availability of Organic Seed: The NOP regulations at 7 CFR § 205.204 require 

that organic producers use organic seeds, annual seedlings, and planting stock. The regulations 

allow producers to utilize non-organic seeds and annual or perennial planting stock when 

organic varieties are not commercially available. 

The term “commercial availability” is defined under section 205.2 (Terms Defined) as: 

The ability to obtain a production input in an appropriate form, quality, or quantity to fulfill an 

essential function in a system of organic production or handling, as determined by the certifying 

agent in the course of reviewing the organic plan. 

4 Title 7 CFR Part 205 - National Organic Program

179/186
Discussion of Public Comments & Subcommittee Evaluation

This section summarizes the comments from the public and then reports on the GMO 

subcommittee’s thinking for each point raised. Quotes were taken from selected comments that 

illustrate each point, but not every commenter is quoted separately.

The large majority of public commenters wants to keep GMOs out of the organic system and is

in favor of a proposal to address seed purity. Among the commenters from affected parties 

(farmers, seed companies, trade associations, certifiers), the majority were in favor and felt they 

could meet such a standard with enough time. The primary areas of concern among organic 

industry stakeholders about the example seed purity standard that was described in the 

Discussion Document are the following:

• Inconsistent with the "process" standard

• Not enough data about testing protocols and thresholds for rejection

• Not ready to implement because source material is unavailable

• Expensive for organic farmers, especially organic small-scale farmers

• Seed availability decreased, especially organic seed

• Policy must distinguish between organic and conventional seed

• Genetic diversity decreased because of contamination of breeding lines

• Should be the responsibility of the greater USDA to regulate, not just NOP

We will address each point with reference to public comment in particular.

Inconsistent with the "process" standard

Public Comment

"...setting a purity standard can be consistent with a process-based standard when analytical 

limits are used to verify that adequate measures are in place to prevent contamination with 

excluded methods. This can be analogous to the detection of prohibited pesticides. Organic 

standards prohibit the use of toxic and synthetic pesticides. Analytical testing and rejection 

levels are used to verify this process- based standard." (Organic Trade Association [OTA] public 

comment, spring 2013)

Subcommittee Evaluation

The Subcommittee agrees with this position and would like to move toward a recommendation, 

although there are some hurdles to overcome as discussed below. Any seed purity testing 

would be an analytical enforcement tool that would be used to supplement an overall seed 

purity protocol required as part of the organic systems plan that would include documenting 

seed sources, selection of appropriate field locations, maintaining appropriate buffer zones, and 

documenting equipment cleaning for both planting and harvest. 

Not enough data about testing protocols and thresholds for rejection

Public Comment

The request for company data that was included in the discussion document did not result in 

enough information to help the subcommittee know what is currently occurring in the 

marketplace. “USDA should conduct a comprehensive analysis of existing contamination at the 

seed level." (Organic Seed Association [OSA] public comment, fall 2012) This recommendation 

coincides with one made in 2012 by the USDA Advisory Committee on Biotechnology and 21st

180/186
Century Agriculture (“AC21”). 5 USDA is currently developing implementation plans for the AC21 

2012 recommendations.

Subcommittee Evaluation

The subcommittee supports any efforts made by the USDA in collecting relevant information. If 

good data is not provided through the NOSB public comment process, the NOSB does not have 

the ability to mandate data collection, only to suggest it to other parts of USDA. Any 

recommendation would have a significant amount of time for phase-in so that data can be 

collected and analyzed. We hope that such data will help inform us as to the scope of the 

problem. 

Not ready to implement because source material is unavailable

Public Comment

Several commenters in the seed trade commented on the difficulty of finding breeding lines that 

are not already contaminated. Often they cannot test their incoming materials due to licensing 

rules.

Subcommittee Evaluation

We agree that source materials are limited and will become less and less available and 

contamination worse and worse in the future. Therefore, any proposal that eventually is 

recommended will certainly require a long lead time for starting a testing scheme and even 

longer for breeders and researchers to evaluate source materials that can comply. Our goal is to 

create a thriving organic seed industry for all crops, and we believe that to do this we need 

better tools to keep GMOs from encroaching into our seed supply and crops. 

Expensive for organic farmers, especially organic small-scale farmers

Public Comment

Many stakeholders pointed out that organic farmers already assume the burden of taking many 

preventive measures to keep GMOs out of their products. Maintaining buffer zones in fields, 

delayed planting to avoid GMO pollen, cleaning procedures for harvest and seed cleaning 

equipment and final product testing are a few of such measures.

"The issue of both cost effectiveness and costs of testing escalating to the point of being 

prohibitive could actually reduce organic acreage or cause certified operators to leave the 

organic industry altogether." (OFARM public comment, fall 2012) This was a common sentiment 

expressed by seed companies and farmers and their representatives.

Subcommittee Evaluation

After reading all the public comment and inviting several key stakeholders to the subcommittee 

calls, the subcommittee discussed how any threshold for GMO contamination of seed would 

place a significant burden on organic farmers and small seed companies, and such cost burden 

should be coupled with liability for the GMO patent holders.. 

The subcommittee is unanimous in believing that the costs of preventing contamination should 

be borne by the GE seed patent holders. We don't believe that farmers who grow GMO crops 

5 The AC21 recommendation was part of the report, “Enhancing Coexistence.” The specific 

recommendation at page 22 reads, “Conduct research...including...gathering and aggregating, on an 

ongoing basis, data from seed companies on unintended GE presence in commercial non-GE seed 

supplies intended for IP uses.” 

181/186
should be held responsible for losses. The patent holders need to be held accountable for the

pollution caused by the escape of their genes into organic fields through seeds. 

Most of the public comment from direct stakeholders was concerned with cost, timeline for 

implementation, and logistics of obtaining and maintaining pure source material, but not as 

much with the reasoning behind needing an analytical tool, or the specifics of a seed sampling 

size. 

Achieving true accountability for the pollution of organic crops from those who cause it is a 

challenging concept to implement. The Subcommittee acknowledges that this issue goes 

beyond the scope of the NOSB and the NOP and therefore the usual type of NOSB 

recommendation cannot be used to reach this goal. We recognize that without larger changes 

outside the scope of NOP and USDA itself, imposing a seed purity standard on organic 

producers might be damaging to the overall growth of organic production and use of organic 

seed.

Nonetheless, three concepts for compensation by outside entities were discussed by the 

subcommittee, with the acknowledgement that neither the NOSB nor the NOP has the ability to 

implement any of them alone. Each of these concepts would appear to require Congressional 

action. These suggestions would only apply to compensation for seed purity testing and 

compensation when GE contamination is found. 

A. CERCLA model - The objective of the Comprehensive Environmental Response, 

Compensation, and Liability Act (CERCLA or Superfund) is to clean up uncontrolled 

releases of hazardous substances. The name “Superfund” comes from the fact that 

clean-up activities are financed by a fund originally created by taxes on oil and chemical 

industries.6

 We discussed applying the Superfund model to compensation for testing for 

seed purity and contamination. 

B. Crop Insurance for polluters - Rather than make organic farmers pay for crop insurance, we 

would like the patent holders of GMO seed be required to get crop insurance in order to 

sell the seed. This could be built into the cost of the GMO seed. A portion of this crop 

insurance fund would be available to pay for the organic farmers and organic seed 

companies to test seed lots. 

C. Government administered compensation - This concept is for the government to use 

taxpayer money or perhaps money assessed through the patent process and regulatory 

review of new GMO crops and products. This would make sure that conventional 

farmers would not bear the burden directly but the patent holders would. We realize that 

this approach would require Congressional action. However, this would place 

responsibility on the parties who are responsible for the pollution. 

The topic of “GMO contamination insurance” for organic producers was also discussed, along 

the lines of what was suggested by the AC21 recommendations. Discussion points included 

whether insurance should be voluntary or mandatory and whether this was a solution for 

enough people to make pursuing it worthwhile. The majority of the past and present members of 

the subcommittee felt this approach was untenable because it places the entire burden on 

6 Three dedicated taxes on oil and chemical industries -- on petroleum, chemical feedstock, and corporate 

income6

— historically provided the majority of the trust fund’s income. Those taxes expired at the end of 

1995, however, and the amount of unobligated money in the fund gradually dwindled. Since President 

Obama has been in office, he has regularly proposed reinstatement of the Superfund taxes. General 

funds have been used for site cleanup meanwhile.

182/186
organic producers and involves no acknowledgement or accountability on the part of the patent 

holders, or any incentive for them to contain their pollution. 

Seed availability decreased, especially organic seed

Public Comment

Commenters expressed that seed availability would certainly decrease if the proposal went into 

effect soon. Several suggested that a long time frame for the entire organic community to start 

working towards this as a goal could make this achievable in the future. 

Subcommittee Evaluation

Increasing the variety and quantity of organic seed is very important and the NOSB has issued 

several past recommendations in support of organic seed. Yet, just as trueness-to-type, good 

viability, and high performance are important traits in seeds for organic systems, so is keeping 

GMOs out of the seed supply.

We recognize that there are significant challenges to overcome and among them are the needs 

for data on what seed is already available that can meet the standard, as well as a need for 

basic research on whether GMO content in breeding lines can be bred out over time to re-gain a 

wider assortment of germplasm to produce clean organic seed.

An important step would be to create a timeline by which to measure forward progress. We want 

all stakeholders notified of our intentions to keep working on this topic, and would like continued 

support from stakeholders on this effort if we are ever able to move forward with a 

recommendation. 

Policy must distinguish between organic and conventional seed 

Public Comment

Several commenters called for a distinction in policy between testing of organic seed and testing 

conventional seed used in organic production. "The organic community needs to aggressively 

support and increase the use of organic seed, or we risk losing access to many genetic traits 

and varieties..."(Blue River Hybrids public comment, Fall, 2012)

Subcommittee Evaluation

The NOSB as a whole has issued recommendations to favor the use of organic seeds. Yet we

are concerned that preferring contaminated organic seeds over identity-preserved non-GMO 

conventional seed may not be desirable. We welcome more public comment on how a seed 

purity standard should address this dilemma, including incentives to favor the use of organic 

seed. Possibilities to favor organic seed in any future proposal could include a longer timeline 

for implementation, a less stringent sample size, less frequency of testing based on other 

preventative practices taken, or other ideas for spurring on the use of organic seed.

Genetic diversity decreased because of contamination of breeding lines

Public Comment

Not only has the seed supply available to organic farmers been contaminated, but the breeding 

lines and foundation stock used to produce seed have often been contaminated. From the 

survey of seed companies done by the Organic Seed Alliance came the following information: 

"....some companies relayed that it’s not uncommon for germplasm licensing agreements to 

prohibit testing for GE content. This puts companies who want to protect their reputation as a 

supplier of “clean” seed in a vulnerable position of risking litigation if they decide to test illegally. 

183/186
Public plant breeders have also relayed similar experiences regarding limited access to 

germplasm that does not come with restrictions or fears of unintended patent infringement" 

(OSA public comment, fall 2012). If we do not act soon, the choice of available breeding 

material that meets any seed purity standard may end up being of poorer genetic quality as a 

result (OSA public comment, fall 2012).

Subcommittee Evaluation

The subcommittee strongly agrees with this concern and believes it is a vital part of an organic 

system to encourage genetic diversity. Addressing this issue will take even longer than it may 

take to bring a standard into existence. Therefore we would suggest a longer period of time for 

breeding lines and foundation seed, such as the 5 additional years suggested in the Discussion 

Document, with a variance or waiver to provide yet additional time if found to be necessary. We 

intend to re-visit this over the time we spend doing further work on this issue, while at the same 

time putting forward a strong call for research into procuring and maintaining clean breeding 

materials. We additionally recommend the development of more strategies that the GMO farmer 

may use to reduce or eliminate contamination from GMO agriculture farm systems. 

Should be the responsibility of the greater USDA to regulate, not just NOP

Public Comment

In light of recent events concerning the detection of GMO wheat escaping into a farm field, the 

lack of regulation and oversight of genetically modified crops has become more and more 

apparent. Many of our public commenters expressed this quite eloquently.

"USDA should play an assertive role in safeguarding the private property rights of 

American organic farmers when it comes to preventing unwanted trespass and genetic 

drift by GE patent-holders onto organic farms. Organic farmers have a right to farm in 

the way they choose on their farm without threat of intimidation and transgenic trespass." 

(Organic Seed Grower and Trade Association [OSGATA] public comment, spring 2013)

"A meaningful regulatory framework for GE seed and crops would mandate proven 

containment measures in the field, from field trials to commercialized production, and 

strict post-market monitoring and evaluation of their effects on the environment and 

other production systems and markets, especially organic. The framework would also 

include routine monitoring of gene flow, and a comprehensive evaluation of the genetic 

purity of our nation’s foundation seed." (OSA public comment, fall 2012)

"Demand that Congress create laws and authorize funds for the USDA to map planting 

of GE crops and non GE crop contamination, and hold contaminators accountable for 

cleanup cost and organic farmer losses." (Dietrick Inst. for Applied Insect Ecology public 

comment, spring 2013)

Subcommittee Evaluation

We echo the points raised by our stakeholders above. Organic producers are already going 

more than half way to bear the costs of maintaining organic integrity. It is not the conventional 

farmers who should be penalized for this; it is the patent holders who cannot keep their genes 

contained and the regulators who have not done enough to enable all farmers to produce crops 

in the way that they choose. We also recognize that the regulators are hampered by underlying 

limitations in their authority to act on the concerns of the stakeholders on GMO issues. However 

change can only happen by speaking out at every opportunity and this report is the ad hoc GMO 

subcommittee's opportunity to do so.

184/186
Conclusions

The GMO ad hoc Subcommittee has concluded that a genetic purity standard is desirable for 

seed used in organic production systems where there are conventional genetically engineered 

varieties of that crop. The main reasons why it is desirable are: 

 

•• It can be a useful tool to verify compliance with the excluded methods process standard, 

much as residue testing is a tool to verify compliance with other sections of the rule.

•• The marketplace is increasingly demanding it. As awareness of GMOs grow among 

consumers because of labeling efforts, the consumers need assurance that organic 

represents a label from which GMOs are truly excluded, thereby leading to organic food 

that is less likely to be contaminated with GMOs. . 

•• There is no way to prove irreparable harm when a contamination event occurs if there is 

no benchmark for rejection from the organic supply chain.

•• Developers of future GMO traits and varieties are claiming that there is no impact of their 

agricultural trespass on organic producers because there are no grounds for rejecting 

contaminated seeds. 

•• Genetic engineering is not compatible with organic food or farming and the organic 

community needs all the tools it can possibly use to keep GMOs out.

We believe that this is an urgent issue but as we have noted above, there are several 

fundamental problems with designing and implementing such a standard (lack of clean breeding 

lines, disincentives to be organically certified, lack of data on where the problem actually exists, 

excessive costs, etc.). Because of these unknowns and obstacles, it is not possible to put 

forward a workable standard at this time.

Based on the comments received and our own discussion, we believe that an eventual seed 

purity standard should have the following features: 

• The standard we have discussed would be based on presence or absence of GE 

content in a specified seed sample size (e.g. 3000 seeds). The use of terms like “nondetect” or” none found in the sample” is consistent with this goal, and less confusing 

than the statistical expression summarizing what “none found” in a sample means 

relative to the level of certainty that the whole lot is not contaminated. We see this as an 

analytical tool to verify compliance with the process-based standard for excluded 

methods.

• Organic seed growers should be protected from and compensated for contamination of 

their seed crops.

• The cost should not be borne by organic seed producers. The cost of seed testing and 

costs resulting from detected contamination of the seed supply should be borne by the 

patent holders of the contaminating genes.

• The standard should apply equally to organic seed and untreated conventional seed 

used for planting organic fields, however provisions to favor organic seeds should be 

explored. 

• More details on how often to test, what method of testing, and what to do with seed that 

does not pass should be worked out between now and the time this moves forward, 

acknowledging that these issues and detection limits can change as technology 

advances.

• Initially, additional time will be needed to achieve purity for breeding lines and foundation 

seed, and this time period should be extended with variances or waivers based on 

experience and need. 

185/186
As noted in this report, the third bullet point above is outside the authority of the NOSB and the 

National Organic Program. The subcommittee welcomes constructive suggestions from the 

public on funding mechanisms and the other points raised in this discussion that are within the 

scope of the NOP and NOSB to work on going forward. 

We understand that the role of the NOP is limited in this matter, and in fact some points raised 

extend beyond the USDA and into the Coordinated Framework7

. Therefore, solution-oriented 

comments to this report must be addressed to areas within our ability to work on.

The subcommittee also urges increased research into testing protocols, contamination 

avoidance methods and technologies, methods to minimize or eliminate contamination from 

breeding lines and foundation seed, rejection levels, and amount of contamination currently 

being found in the field be prioritized by the USDA and organic funders. These needs should be 

included in the NOSB’s research recommendations to USDA.

Subcommittee Vote

Motion to accept the Seed Purity report presented February 25 as outlined above.

Motion by: Zea Sonnabend 

Seconded by: C. Reuben Walker 

Yes: 5 No: 0 Absent: 1 Abstain: 0 Recuse: 0 

Approved by Zea Sonnabend, Subcommittee Chair, to transmit to NOSB February 25, 

2014

7 The U.S. “Coordinated Framework for Regulation of Biotechnology” document was issued by the Office of 

Science and Technology Policy in 1986. See Fed Regist. 51 (123): 23302–50.

186/186